TriangleNCT03544281 · OUTCOME
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Score on scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])
What was measured
The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.
Analysis population: All Treated. Only those participants with data available at specified time points have been analyzed.
Groups in this outcome
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
Reported measurements
GHS/QoL, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 65.8 | 25.29 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 69.4 | 31.55 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 58.3 | 14.16 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 60.4 | 13.18 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 56.2 | 23.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 67.6 | 9.72 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 63.6 | 20.84 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 56.1 | 20.78 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 60.2 | 26.61 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 55.0 | 24.60 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 63.3 | 16.29 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 67.7 | 15.71 | Not reported | Not reported | Not reported |
GHS/QoL, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | -50.0 | 22.05 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 4.2 | 17.68 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | -4.2 | 14.43 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | -16.7 | 18.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | -10.0 | 34.05 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -8.3 | 11.79 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 0.0 | 13.94 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | -14.6 | 25.88 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | -4.2 | 17.68 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | -8.3 | 9.62 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 18.7 | 23.94 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4.2 | 20.97 | Not reported | Not reported | Not reported |
PF, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 67.3 | 23.82 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 88.9 | 13.88 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 78.7 | 15.65 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 73.3 | 21.97 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 75.0 | 15.60 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 84.4 | 17.95 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 85.5 | 17.34 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 70.9 | 25.69 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 66.7 | 31.27 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 78.7 | 19.58 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 82.0 | 10.91 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 89.4 | 11.48 | Not reported | Not reported | Not reported |
PF, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | -17.8 | 48.23 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 13.3 | 18.86 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | -6.7 | 24.94 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 0.0 | 33.11 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | -5.3 | 22.80 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -10.0 | 14.14 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | -1.1 | 9.81 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | -12.5 | 27.93 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 3.3 | 4.71 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | -10.0 | 15.87 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | -11.7 | 42.64 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | -1.7 | 12.62 | Not reported | Not reported | Not reported |
RF, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 66.7 | 30.43 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 88.9 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 76.7 | 22.50 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 72.9 | 29.46 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 68.1 | 21.86 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 72.2 | 22.05 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 81.8 | 24.10 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 57.6 | 36.03 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 70.4 | 33.10 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 73.3 | 19.56 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 71.7 | 22.29 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 89.6 | 19.80 | Not reported | Not reported | Not reported |
RF, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | -22.2 | 69.39 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 8.3 | 34.69 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4.2 | 34.36 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | -6.7 | 25.28 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -8.3 | 35.36 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | -11.1 | 27.22 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 0.0 | 32.12 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | -20.8 | 34.36 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 20.8 | 36.96 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | -4.2 | 28.46 | Not reported | Not reported | Not reported |
EF, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 76.7 | 25.40 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 86.1 | 4.81 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 77.5 | 18.02 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 76.0 | 16.93 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 70.8 | 20.87 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 94.4 | 7.22 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 73.5 | 25.50 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 68.9 | 28.89 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 83.3 | 13.18 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 78.3 | 17.21 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 83.3 | 16.20 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 91.7 | 8.91 | Not reported | Not reported | Not reported |
EF, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 5.6 | 29.27 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | -12.5 | 5.89 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 10.4 | 15.77 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 3.3 | 33.64 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 0.0 | 11.79 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | -6.3 | 25.49 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | -12.5 | 5.89 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 2.1 | 14.23 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | -12.5 | 15.96 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 6.3 | 12.50 | Not reported | Not reported | Not reported |
CF, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 75.0 | 16.20 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 88.9 | 9.62 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 71.7 | 24.91 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 72.9 | 21.71 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 81.9 | 19.41 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 87.0 | 13.89 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 81.8 | 17.41 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 74.2 | 15.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 74.1 | 16.90 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 83.3 | 22.22 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 95.0 | 8.05 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 91.7 | 12.60 | Not reported | Not reported | Not reported |
CF, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | -16.7 | 44.10 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 8.3 | 11.79 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 16.7 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 12.5 | 20.97 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | -10.0 | 25.28 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 2.8 | 6.80 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 0.0 | 17.82 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 8.3 | 11.79 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | -8.3 | 21.52 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | -16.7 | 27.22 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | -8.3 | 9.62 | Not reported | Not reported | Not reported |
SF, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 71.7 | 26.12 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 88.9 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 80.0 | 18.92 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 77.1 | 21.71 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 76.4 | 20.67 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 83.3 | 18.63 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 77.3 | 28.16 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 71.2 | 28.95 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 72.2 | 34.36 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 68.3 | 34.65 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 73.3 | 17.92 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 75.0 | 23.57 | Not reported | Not reported | Not reported |
SF, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | -27.8 | 63.10 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 8.3 | 11.79 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 0.0 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | -12.5 | 36.96 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | -6.7 | 25.28 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -16.7 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | -11.1 | 22.77 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | -27.1 | 36.66 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 8.3 | 16.67 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | -12.5 | 34.36 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 16.7 | 19.25 | Not reported | Not reported | Not reported |
Fatigue, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 46.7 | 23.89 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 25.9 | 16.97 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 31.1 | 8.76 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 38.9 | 19.70 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 34.3 | 19.22 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 28.4 | 21.60 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 29.3 | 13.40 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 34.3 | 26.51 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 30.9 | 30.32 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 32.2 | 23.10 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 37.8 | 25.77 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 31.9 | 3.93 | Not reported | Not reported | Not reported |
Fatigue, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3.7 | 35.72 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | -11.1 | 15.71 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 5.6 | 6.42 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 2.8 | 24.64 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 13.3 | 28.76 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -11.1 | 15.71 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | -3.7 | 13.46 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 16.7 | 33.60 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 11.1 | 15.71 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 2.8 | 18.98 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | -2.8 | 41.94 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | -11.1 | 12.83 | Not reported | Not reported | Not reported |
N/V, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 11.7 | 15.81 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 11.7 | 15.81 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 2.1 | 5.89 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 8.3 | 15.08 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 3.7 | 7.35 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 4.5 | 7.78 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 1.5 | 5.03 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 5.6 | 8.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 8.3 | 11.79 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 5.0 | 8.05 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 2.1 | 5.89 | Not reported | Not reported | Not reported |
N/V, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 11.1 | 41.94 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4.2 | 8.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | -4.2 | 8.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | -6.7 | 30.28 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -8.3 | 11.79 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 5.6 | 17.21 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 6.3 | 12.40 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | -4.2 | 8.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4.2 | 8.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 0.0 | 13.61 | Not reported | Not reported | Not reported |
Pain, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 46.7 | 35.83 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 22.2 | 25.46 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 36.7 | 24.60 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 37.5 | 31.81 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 41.7 | 26.11 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 24.1 | 29.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 28.8 | 25.92 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 34.8 | 34.52 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 42.6 | 33.45 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 28.3 | 20.86 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 36.7 | 25.82 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 22.9 | 21.71 | Not reported | Not reported | Not reported |
Pain, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 0.0 | 16.67 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | -16.7 | 47.14 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | -12.5 | 15.96 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | -25.0 | 50.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 20.0 | 36.13 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | -5.6 | 8.61 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 12.5 | 30.54 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | -8.3 | 11.79 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 25.0 | 31.91 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | -4.2 | 43.83 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8.3 | 16.67 | Not reported | Not reported | Not reported |
Dyspnoea, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 33.3 | 35.14 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 11.1 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 13.3 | 17.21 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 12.5 | 17.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 22.2 | 25.95 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 11.1 | 16.67 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 15.2 | 17.41 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 33.3 | 36.51 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 14.8 | 24.22 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 16.7 | 17.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 16.7 | 17.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8.3 | 15.43 | Not reported | Not reported | Not reported |
Dyspnoea, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 33.3 | 33.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | -16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 25.0 | 31.91 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 16.7 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 0.0 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | -5.6 | 13.61 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 12.5 | 39.59 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 16.7 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
Insomnia, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 40.0 | 26.29 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 44.4 | 38.49 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 33.3 | 27.22 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 29.2 | 21.36 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 36.1 | 33.21 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 25.9 | 14.70 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 27.3 | 25.03 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 33.3 | 33.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 37.0 | 38.89 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 33.3 | 31.43 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 30.0 | 33.15 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8.3 | 15.43 | Not reported | Not reported | Not reported |
Insomnia, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 0.0 | 33.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 0.0 | 47.14 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | -16.7 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 0.0 | 27.22 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | -6.7 | 27.89 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 5.6 | 25.09 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8.3 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 0.0 | 47.14 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | -16.7 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 0.0 | 54.43 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
AL, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 23.3 | 27.44 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 6.7 | 14.05 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 25.0 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 13.9 | 22.29 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 7.4 | 14.70 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 12.1 | 16.82 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 9.1 | 15.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 22.2 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 26.7 | 26.29 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 6.7 | 14.05 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 12.5 | 24.80 | Not reported | Not reported | Not reported |
AL, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 22.2 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 16.7 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | -16.7 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 0.0 | 33.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | -4.2 | 21.36 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | -8.3 | 41.94 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 25.0 | 50.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | -8.3 | 16.67 | Not reported | Not reported | Not reported |
Constipation, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 20.0 | 28.11 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 6.7 | 14.05 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 12.5 | 17.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 16.7 | 26.59 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 11.1 | 16.67 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 12.1 | 16.82 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 9.1 | 15.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 7.4 | 22.22 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 13.3 | 17.21 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 20.0 | 32.20 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8.3 | 15.43 | Not reported | Not reported | Not reported |
Constipation, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 16.7 | 33.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 16.7 | 33.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 0.0 | 47.14 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 4.2 | 21.36 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | -25.0 | 31.91 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 16.7 | 19.25 | Not reported | Not reported | Not reported |
Diarrhoea, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 6.7 | 14.05 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8.3 | 15.43 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 19.4 | 22.29 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 11.1 | 16.67 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 9.1 | 15.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 21.2 | 34.23 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 11.1 | 33.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 6.7 | 21.08 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 6.7 | 14.05 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 12.5 | 17.25 | Not reported | Not reported | Not reported |
Diarrhoea, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 22.2 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 33.3 | 47.14 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 8.3 | 31.91 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8.3 | 16.67 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | -13.3 | 29.81 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -16.7 | 23.57 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | -5.6 | 13.61 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 0.0 | 30.86 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 0.0 | 27.22 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 16.7 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | -8.3 | 31.91 | Not reported | Not reported | Not reported |
FD, Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 30.0 | 33.15 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 11.1 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 30.0 | 36.68 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 36.1 | 30.01 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 7.4 | 14.70 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 24.2 | 36.79 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 15.2 | 17.41 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 25.9 | 27.78 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 26.7 | 37.84 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 20.0 | 35.83 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 20.8 | 35.36 | Not reported | Not reported | Not reported |
FD, CFB to EoT
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 2 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 33.3 | 57.74 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 8.3 | 31.91 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | -13.3 | 18.26 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 4.2 | 21.36 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 0.0 | 0.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 16.7 | 19.25 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 8.3 | 16.67 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | -16.7 | 33.33 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 25.29
- value
- 65.8
- group Id
- OG001
- spread
- 31.55
- value
- 69.4
- group Id
- OG002
- spread
- 14.16
- value
- 58.3
- group Id
- OG003
- spread
- 13.18
- value
- 60.4
- group Id
- OG004
- spread
- 23.33
- value
- 56.2
- group Id
- OG005
- spread
- 9.72
- value
- 67.6
- group Id
- OG006
- spread
- 20.84
- value
- 63.6
- group Id
- OG007
- spread
- 20.78
- value
- 56.1
- group Id
- OG008
- spread
- 26.61
- value
- 60.2
- group Id
- OG009
- spread
- 24.60
- value
- 55.0
- group Id
- OG010
- spread
- 16.29
- value
- 63.3
- group Id
- OG011
- spread
- 15.71
- value
- 67.7
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 10
- group Id
- OG011
- value
- 8
- units
- Participants
- title
- GHS/QoL, Baseline (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 22.05
- value
- -50.0
- group Id
- OG001
- spread
- 17.68
- value
- 4.2
- group Id
- OG002
- spread
- 14.43
- value
- -4.2
- group Id
- OG003
- spread
- 18.00
- value
- -16.7
- group Id
- OG004
- spread
- 34.05
- value
- -10.0
- group Id
- OG005
- spread
- 11.79
- value
- -8.3
- group Id
- OG006
- spread
- 13.94
- value
- 0.0
- group Id
- OG007
- spread
- 25.88
- value
- -14.6
- group Id
- OG008
- spread
- 17.68
- value
- -4.2
- group Id
- OG009
- spread
- 9.62
- value
- -8.3
- group Id
- OG010
- spread
- 23.94
- value
- 18.7
- group Id
- OG011
- spread
- 20.97
- value
- 4.2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- units
- Participants
- title
- GHS/QoL, CFB to EoT
- categories
- measurements
- group Id
- OG000
- spread
- 23.82
- value
- 67.3
- group Id
- OG001
- spread
- 13.88
- value
- 88.9
- group Id
- OG002
- spread
- 15.65
- value
- 78.7
- group Id
- OG003
- spread
- 21.97
- value
- 73.3
- group Id
- OG004
- spread
- 15.60
- value
- 75.0
- group Id
- OG005
- spread
- 17.95
- value
- 84.4
- group Id
- OG006
- spread
- 17.34
- value
- 85.5
- group Id
- OG007
- spread
- 25.69
- value
- 70.9
- group Id
- OG008
- spread
- 31.27
- value
- 66.7
- group Id
- OG009
- spread
- 19.58
- value
- 78.7
- group Id
- OG010
- spread
- 10.91
- value
- 82.0
- group Id
- OG011
- spread
- 11.48
- value
- 89.4
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 10
- group Id
- OG011
- value
- 8
- units
- Participants
- title
- PF, Baseline (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 48.23
- value
- -17.8
- group Id
- OG001
- spread
- 18.86
- value
- 13.3
- group Id
- OG002
- spread
- 24.94
- value
- -6.7
- group Id
- OG003
- spread
- 33.11
- value
- 0.0
- group Id
- OG004
- spread
- 22.80
- value
- -5.3
- group Id
- OG005
- spread
- 14.14
- value
- -10.0
- group Id
- OG006
- spread
- 9.81
- value
- -1.1
- group Id
- OG007
- spread
- 27.93
- value
- -12.5
- group Id
- OG008
- spread
- 4.71
- value
- 3.3
- group Id
- OG009
- spread
- 15.87
- value
- -10.0
- group Id
- OG010
- spread
- 42.64
- value
- -11.7
- group Id
- OG011
- spread
- 12.62
- value
- -1.7
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- units
- Participants
- title
- PF, CFB to EoT
- categories
- measurements
- group Id
- OG000
- spread
- 30.43
- value
- 66.7
- group Id
- OG001
- spread
- 19.25
- value
- 88.9
- group Id
- OG002
- spread
- 22.50
- value
- 76.7
- group Id
- OG003
- spread
- 29.46
- value
- 72.9
- group Id
- OG004
- spread
- 21.86
- value
- 68.1
- group Id
- OG005
- spread
- 22.05
- value
- 72.2
- group Id
- OG006
- spread
- 24.10
- value
- 81.8
- group Id
- OG007
- spread
- 36.03
- value
- 57.6
- group Id
- OG008
- spread
- 33.10
- value
- 70.4
- group Id
- OG009
- spread
- 19.56
- value
- 73.3
- group Id
- OG010
- spread
- 22.29
- value
- 71.7
- group Id
- OG011
- spread
- 19.80
- value
- 89.6
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 10
- group Id
- OG011
- value
- 8
- units
- Participants
- title
- RF, Baseline (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 69.39
- value
- -22.2
- group Id
- OG001
- spread
- 23.57
- value
- 16.7
- group Id
- OG002
- spread
- 34.69
- value
- 8.3
- group Id
- OG003
- spread
- 34.36
- value
- 4.2
- group Id
- OG004
- spread
- 25.28
- value
- -6.7
- group Id
- OG005
- spread
- 35.36
- value
- -8.3
- group Id
- OG006
- spread
- 27.22
- value
- -11.1
- group Id
- OG007
- spread
- 32.12
- value
- 0.0
- group Id
- OG008
- spread
- 0.00
- value
- 0.0
- group Id
- OG009
- spread
- 34.36
- value
- -20.8
- group Id
- OG010
- spread
- 36.96
- value
- 20.8
- group Id
- OG011
- spread
- 28.46
- value
- -4.2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- units
- Participants
- title
- RF, CFB to EoT
- categories
- measurements
- group Id
- OG000
- spread
- 25.40
- value
- 76.7
- group Id
- OG001
- spread
- 4.81
- value
- 86.1
- group Id
- OG002
- spread
- 18.02
- value
- 77.5
- group Id
- OG003
- spread
- 16.93
- value
- 76.0
- group Id
- OG004
- spread
- 20.87
- value
- 70.8
- group Id
- OG005
- spread
- 7.22
- value
- 94.4
- group Id
- OG006
- spread
- 25.50
- value
- 73.5
- group Id
- OG007
- spread
- 28.89
- value
- 68.9
- group Id
- OG008
- spread
- 13.18
- value
- 83.3
- group Id
- OG009
- spread
- 17.21
- value
- 78.3
- group Id
- OG010
- spread
- 16.20
- value
- 83.3
- group Id
- OG011
- spread
- 8.91
- value
- 91.7
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 10
- group Id
- OG011
- value
- 8
- units
- Participants
- title
- EF, Baseline (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 29.27
- value
- 5.6
- group Id
- OG001
- spread
- 5.89
- value
- -12.5
- group Id
- OG002
- spread
- 0.00
- value
- 0.0
- group Id
- OG003
- spread
- 15.77
- value
- 10.4
- group Id
- OG004
- spread
- 33.64
- value
- 3.3
- group Id
- OG005
- spread
- 23.57
- value
- -16.7
- group Id
- OG006
- spread
- 11.79
- value
- 0.0
- group Id
- OG007
- spread
- 25.49
- value
- -6.3
- group Id
- OG008
- spread
- 5.89
- value
- -12.5
- group Id
- OG009
- spread
- 14.23
- value
- 2.1
- group Id
- OG010
- spread
- 15.96
- value
- -12.5
- group Id
- OG011
- spread
- 12.50
- value
- 6.3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- units
- Participants
- title
- EF, CFB to EoT
- categories
- measurements
- group Id
- OG000
- spread
- 16.20
- value
- 75.0
- group Id
- OG001
- spread
- 9.62
- value
- 88.9
- group Id
- OG002
- spread
- 24.91
- value
- 71.7
- group Id
- OG003
- spread
- 21.71
- value
- 72.9
- group Id
- OG004
- spread
- 19.41
- value
- 81.9
- group Id
- OG005
- spread
- 13.89
- value
- 87.0
- group Id
- OG006
- spread
- 17.41
- value
- 81.8
- group Id
- OG007
- spread
- 15.57
- value
- 74.2
- group Id
- OG008
- spread
- 16.90
- value
- 74.1
- group Id
- OG009
- spread
- 22.22
- value
- 83.3
- group Id
- OG010
- spread
- 8.05
- value
- 95.0
- group Id
- OG011
- spread
- 12.60
- value
- 91.7
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 10
- group Id
- OG011
- value
- 8
- units
- Participants
- title
- CF, Baseline (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 44.10
- value
- -16.7
- group Id
- OG001
- spread
- 11.79
- value
- 8.3
- group Id
- OG002
- spread
- 19.25
- value
- 16.7
- group Id
- OG003
- spread
- 20.97
- value
- 12.5
- group Id
- OG004
- spread
- 25.28
- value
- -10.0
- group Id
- OG005
- spread
- 23.57
- value
- -16.7
- group Id
- OG006
- spread
- 6.80
- value
- 2.8
- group Id
- OG007
- spread
- 17.82
- value
- 0.0
- group Id
- OG008
- spread
- 11.79
- value
- 8.3
- group Id
- OG009
- spread
- 21.52
- value
- -8.3
- group Id
- OG010
- spread
- 27.22
- value
- -16.7
- group Id
- OG011
- spread
- 9.62
- value
- -8.3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- units
- Participants
- title
- CF, CFB to EoT
- categories
- measurements
- group Id
- OG000
- spread
- 26.12
- value
- 71.7
- group Id
- OG001
- spread
- 19.25
- value
- 88.9
- group Id
- OG002
- spread
- 18.92
- value
- 80.0
- group Id
- OG003
- spread
- 21.71
- value
- 77.1
- group Id
- OG004
- spread
- 20.67
- value
- 76.4
- group Id
- OG005
- spread
- 18.63
- value
- 83.3
- group Id
- OG006
- spread
- 28.16
- value
- 77.3
- group Id
- OG007
- spread
- 28.95
- value
- 71.2
- group Id
- OG008
- spread
- 34.36
- value
- 72.2
- group Id
- OG009
- spread
- 34.65
- value
- 68.3
- group Id
- OG010
- spread
- 17.92
- value
- 73.3
- group Id
- OG011
- spread
- 23.57
- value
- 75.0
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 10
- group Id
- OG011
- value
- 8
- units
- Participants
- title
- SF, Baseline (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 63.10
- value
- -27.8
- group Id
- OG001
- spread
- 11.79
- value
- 8.3
- group Id
- OG002
- spread
- 23.57
- value
- 0.0
- group Id
- OG003
- spread
- 36.96
- value
- -12.5
- group Id
- OG004
- spread
- 25.28
- value
- -6.7
- group Id
- OG005
- spread
- 0.00
- value
- -16.7
- group Id
- OG006
- spread
- 22.77
- value
- -11.1
- group Id
- OG007
- spread
- 36.66
- value
- -27.1
- group Id
- OG008
- spread
- 0.00
- value
- 0.0
- group Id
- OG009
- spread
- 16.67
- value
- 8.3
- group Id
- OG010
- spread
- 34.36
- value
- -12.5
- group Id
- OG011
- spread
- 19.25
- value
- 16.7
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- units
- Participants
- title
- SF, CFB to EoT
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 10
- group Id
- OG011
- value
- 8
- units
- Participants
- description
- The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
- id
- OG000
- title
- Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
- description
- Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
- id
- OG001
- title
- Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
- description
- Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
- id
- OG002
- title
- Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
- description
- Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
- id
- OG003
- title
- Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
- description
- Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
- id
- OG004
- title
- Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
- description
- Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
- id
- OG005
- title
- Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
- description
- Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
- id
- OG006
- title
- Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
- description
- Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
- id
- OG007
- title
- Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
- description
- Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
- id
- OG008
- title
- Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
- description
- Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
- id
- OG009
- title
- Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
- description
- Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
- id
- OG010
- title
- Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
- description
- Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
- id
- OG011
- title
- Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
- param Type
- MEAN
- population Description
- All Treated. Only those participants with data available at specified time points have been analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])
- title
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
- type
- SECONDARY
- unit Of Measure
- Score on scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice