TriangleNCT03544281 · OUTCOME
Overall Response Rate (ORR) as Defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 4.5 years
What was measured
ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR: negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasmacytomas in the bone marrow; sCR: stringent complete response, CR as above plus normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 h. Confidence intervals were based on the exact method.
Analysis population: All treated population.
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 | 12 |
| 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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex | 58 | Not reported | 27.7 | 84.8 | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex | 75 | Not reported | 19.4 | 99.4 | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex | 69 | Not reported | 38.6 | 90.9 | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex | 69 | Not reported | 41.3 | 89.0 | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex | 50 | Not reported | 21.1 | 78.9 | Not reported |
| Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex | 83 | Not reported | 51.6 | 97.9 | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex | 92 | Not reported | 61.5 | 99.8 | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex | 75 | Not reported | 42.8 | 94.5 | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex | 62 | Not reported | 31.6 | 86.1 | Not reported |
| Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex | 78 | Not reported | 52.4 | 93.6 | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex | 50 | Not reported | 21.1 | 78.9 | Not reported |
| Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex | 69 | Not reported | 41.3 | 89.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 27.7
- upper Limit
- 84.8
- value
- 58
- group Id
- OG001
- lower Limit
- 19.4
- upper Limit
- 99.4
- value
- 75
- group Id
- OG002
- lower Limit
- 38.6
- upper Limit
- 90.9
- value
- 69
- group Id
- OG003
- lower Limit
- 41.3
- upper Limit
- 89.0
- value
- 69
- group Id
- OG004
- lower Limit
- 21.1
- upper Limit
- 78.9
- value
- 50
- group Id
- OG005
- lower Limit
- 51.6
- upper Limit
- 97.9
- value
- 83
- group Id
- OG006
- lower Limit
- 61.5
- upper Limit
- 99.8
- value
- 92
- group Id
- OG007
- lower Limit
- 42.8
- upper Limit
- 94.5
- value
- 75
- group Id
- OG008
- lower Limit
- 31.6
- upper Limit
- 86.1
- value
- 62
- group Id
- OG009
- lower Limit
- 52.4
- upper Limit
- 93.6
- value
- 78
- group Id
- OG010
- lower Limit
- 21.1
- upper Limit
- 78.9
- value
- 50
- group Id
- OG011
- lower Limit
- 41.3
- upper Limit
- 89.0
- value
- 69
- 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
- 12
- 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
- ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR: negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasmacytomas in the bone marrow; sCR: stringent complete response, CR as above plus normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 h. Confidence intervals were based on the exact method.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- All treated population.
- reporting Status
- POSTED
- time Frame
- Up to approximately 4.5 years
- title
- Overall Response Rate (ORR) as Defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM)
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice