TriangleNCT03544281 · OUTCOME
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores
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
What was measured
The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the patient's perception of vision-related functioning and vision-related quality of life. Items were coded to a 0 to 100 scale and were averaged to calculate domains. The composite score ranges from 0 (worst score) to 100 (best score), with higher scores indicating better vision-related functioning. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline 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 | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 9 |
| 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 | 7 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 7 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 10 |
Reported measurements
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 | 11 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 8 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 9 |
| 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 | 7 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 11 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 7 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 85.1 | 11.42 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 89.0 | 18.43 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 91.9 | 10.88 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 91.0 | 11.35 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 88.0 | 16.92 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 95.5 | 4.70 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 96.2 | 5.20 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 95.3 | 4.60 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 90.4 | 7.67 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 94.1 | 8.33 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 93.2 | 7.13 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 94.7 | 5.59 | Not reported | Not reported | Not reported |
Change from baseline (up to approx. 4.5 years)
| 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 | 5 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 1 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 6 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 3 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 0.2 | 13.53 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 12.9 | 22.42 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | -4.5 | 4.04 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | -1.9 | 3.43 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 1.1 | 19.48 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | -8.4 | 13.65 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | -18.3 | 19.96 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | -26.0 | 31.54 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 1.3 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | -13.2 | 25.00 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | -48.9 | 2.35 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | -11.5 | 15.39 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 11.42
- value
- 85.1
- group Id
- OG001
- spread
- 18.43
- value
- 89.0
- group Id
- OG002
- spread
- 10.88
- value
- 91.9
- group Id
- OG003
- spread
- 11.35
- value
- 91.0
- group Id
- OG004
- spread
- 16.92
- value
- 88.0
- group Id
- OG005
- spread
- 4.70
- value
- 95.5
- group Id
- OG006
- spread
- 5.20
- value
- 96.2
- group Id
- OG007
- spread
- 4.60
- value
- 95.3
- group Id
- OG008
- spread
- 7.67
- value
- 90.4
- group Id
- OG009
- spread
- 8.33
- value
- 94.1
- group Id
- OG010
- spread
- 7.13
- value
- 93.2
- group Id
- OG011
- spread
- 5.59
- value
- 94.7
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 7
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 10
- units
- Participants
- title
- Baseline (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 13.53
- value
- 0.2
- group Id
- OG001
- spread
- 22.42
- value
- 12.9
- group Id
- OG002
- spread
- 4.04
- value
- -4.5
- group Id
- OG003
- spread
- 3.43
- value
- -1.9
- group Id
- OG004
- spread
- 19.48
- value
- 1.1
- group Id
- OG005
- spread
- 13.65
- value
- -8.4
- group Id
- OG006
- spread
- 19.96
- value
- -18.3
- group Id
- OG007
- spread
- 31.54
- value
- -26.0
- group Id
- OG008
- value
- 1.3
- group Id
- OG009
- spread
- 25.00
- value
- -13.2
- group Id
- OG010
- spread
- 2.35
- value
- -48.9
- group Id
- OG011
- spread
- 15.39
- value
- -11.5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 5
- units
- Participants
- title
- Change from baseline (up to approx. 4.5 years)
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 7
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 10
- units
- Participants
- description
- The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the patient's perception of vision-related functioning and vision-related quality of life. Items were coded to a 0 to 100 scale and were averaged to calculate domains. The composite score ranges from 0 (worst score) to 100 (best score), with higher scores indicating better vision-related functioning. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline 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
- title
- Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores
- type
- SECONDARY
- unit Of Measure
- Score on scale
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Preserved source evidence · Not medical advice