TriangleNCT03544281 · OUTCOME
Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 4.5 years
What was measured
12-lead electrocardiogram (ECGs) were obtained using an automated ECG machine that automatically calculated the QTcF intervals. QTc values are categorized into the clinical concern ranges which are specific to changes in QTc: 31-60 milliseconds (msec), and \>60 msec, and \>530msec. An increase is defined relative to Baseline. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Data of number of participants with worst-case increase post baseline is presented.
Analysis population: All treated population. 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 | 12 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 4 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 13 |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 16 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 13 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 18 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 12 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 16 |
Reported measurements
Increase of 31-60 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 3 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 5 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 3 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 1 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 3 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 1 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 2 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 5 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 4 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 5 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 5 | Not reported | Not reported | Not reported | Not reported |
Increase of >60 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 3 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 2 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 1 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 2 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
Increase of >530 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 5
- title
- Increase of 31-60 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Increase of >60 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Increase of >530 msec
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 12
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 13
- group Id
- OG009
- value
- 18
- group Id
- OG010
- value
- 12
- group Id
- OG011
- value
- 16
- units
- Participants
- description
- 12-lead electrocardiogram (ECGs) were obtained using an automated ECG machine that automatically calculated the QTcF intervals. QTc values are categorized into the clinical concern ranges which are specific to changes in QTc: 31-60 milliseconds (msec), and \>60 msec, and \>530msec. An increase is defined relative to Baseline. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Data of number of participants with worst-case increase post baseline is presented.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- All treated population. Only those participants with data available at specified time points have been analyzed.
- reporting Status
- POSTED
- time Frame
- Up to approximately 4.5 years
- title
- Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice