TriangleNCT03544281 · OUTCOME
Change From Baseline in Ocular Surface Disease Index (OSDI) Total 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 OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. OSDI consist of three subscales (ocular symptoms: item 1-3; visual related function: item 4-9; environmental triggers: item 10-12). Each item will be graded on a scale of 0 (none of the time or lower disability) to 4 (all of the time or greater disability) with total scores ranging from 0 (no disability) to 100 (complete disability). The total OSDI score was calculated as (sum of scores for all questions answered\*100) divided by (total number of questions answered\*4). Higher scores indicated greater disability. 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 | 9 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 4 |
| 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 | 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 | 12 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 15 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 14 |
Reported measurements
Baseline (Day 1)
| Group | Source count |
|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 4 |
| 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 | 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 | 12 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 10 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 15 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 9 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 14 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 11.1 | 7.58 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 0.8 | 1.56 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 7.8 | 9.30 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 11.4 | 14.26 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 10.8 | 17.20 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 2.4 | 2.79 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 7.8 | 9.94 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 8.0 | 5.66 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 12.4 | 16.42 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 6.3 | 7.71 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 8.6 | 13.61 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 3.3 | 5.58 | 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 | 2 |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 3 |
| 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 | 5 |
| 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 | 6 |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 7 |
| 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 | 9 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 5 |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | -5.2 | 4.42 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 0.6 | 4.10 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 6.9 | 12.03 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 2.2 | 7.19 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 15.2 | 35.94 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 15.9 | 14.80 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 18.7 | 34.95 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 29.3 | 39.18 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 6.1 | 8.59 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 14.4 | 23.26 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 48.3 | 27.42 | Not reported | Not reported | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 19.3 | 14.41 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 7.58
- value
- 11.1
- group Id
- OG001
- spread
- 1.56
- value
- 0.8
- group Id
- OG002
- spread
- 9.30
- value
- 7.8
- group Id
- OG003
- spread
- 14.26
- value
- 11.4
- group Id
- OG004
- spread
- 17.20
- value
- 10.8
- group Id
- OG005
- spread
- 2.79
- value
- 2.4
- group Id
- OG006
- spread
- 9.94
- value
- 7.8
- group Id
- OG007
- spread
- 5.66
- value
- 8.0
- group Id
- OG008
- spread
- 16.42
- value
- 12.4
- group Id
- OG009
- spread
- 7.71
- value
- 6.3
- group Id
- OG010
- spread
- 13.61
- value
- 8.6
- group Id
- OG011
- spread
- 5.58
- value
- 3.3
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 10
- group Id
- OG009
- value
- 15
- group Id
- OG010
- value
- 9
- group Id
- OG011
- value
- 14
- units
- Participants
- title
- Baseline (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 4.42
- value
- -5.2
- group Id
- OG001
- spread
- 4.10
- value
- 0.6
- group Id
- OG002
- spread
- 12.03
- value
- 6.9
- group Id
- OG003
- spread
- 7.19
- value
- 2.2
- group Id
- OG004
- spread
- 35.94
- value
- 15.2
- group Id
- OG005
- spread
- 14.80
- value
- 15.9
- group Id
- OG006
- spread
- 34.95
- value
- 18.7
- group Id
- OG007
- spread
- 39.18
- value
- 29.3
- group Id
- OG008
- spread
- 8.59
- value
- 6.1
- group Id
- OG009
- spread
- 23.26
- value
- 14.4
- group Id
- OG010
- spread
- 27.42
- value
- 48.3
- group Id
- OG011
- spread
- 14.41
- value
- 19.3
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 9
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 7
- units
- Participants
- title
- Change from baseline (up to approx. 4.5 years)
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 10
- group Id
- OG009
- value
- 15
- group Id
- OG010
- value
- 9
- group Id
- OG011
- value
- 14
- units
- Participants
- description
- The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. OSDI consist of three subscales (ocular symptoms: item 1-3; visual related function: item 4-9; environmental triggers: item 10-12). Each item will be graded on a scale of 0 (none of the time or lower disability) to 4 (all of the time or greater disability) with total scores ranging from 0 (no disability) to 100 (complete disability). The total OSDI score was calculated as (sum of scores for all questions answered\*100) divided by (total number of questions answered\*4). Higher scores indicated greater disability. 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 Ocular Surface Disease Index (OSDI) Total Scores
- type
- SECONDARY
- unit Of Measure
- Score on scale
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