TriangleNCT04162210 · OUTCOME
Overall Response Rate (ORR)
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 263 weeks
What was measured
Overall Response Rate is 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. PR: ≥50% reduction of serum M-protein and reduction in 24-hour (h) urinary M-protein by ≥90% or to \<200 mg/24-h; 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; 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.
Analysis population: ITT Population
Groups in this outcome
Belantamab Mafodotin
Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
Pomalidomide Plus Dexamethasone
Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
| Group | Source count |
|---|---|
| Belantamab Mafodotin | 218 |
| Pomalidomide Plus Dexamethasone | 107 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Belantamab Mafodotin | 41 | Not reported | 34.7 | 48.1 | Not reported |
| Pomalidomide Plus Dexamethasone | 36 | Not reported | 26.5 | 45.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.7
- upper Limit
- 48.1
- value
- 41
- group Id
- OG001
- lower Limit
- 26.5
- upper Limit
- 45.4
- value
- 36
- denoms
- counts
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 107
- units
- Participants
- description
- Overall Response Rate is 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. PR: ≥50% reduction of serum M-protein and reduction in 24-hour (h) urinary M-protein by ≥90% or to \<200 mg/24-h; 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; 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
- id
- OG000
- title
- Belantamab Mafodotin
- description
- Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
- id
- OG001
- title
- Pomalidomide Plus Dexamethasone
- param Type
- NUMBER
- population Description
- ITT Population
- reporting Status
- POSTED
- time Frame
- Up to approximately 263 weeks
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice