TriangleNCT01946477 · 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
- Not reported
- Time frame
- From first dose until disease progression or end of treatment whichever occurs first (Up to 130 months)
What was measured
ORR per Modified International Myeloma Working Group (mIMWG) Criteria is defined as the percentage of participants who achieve best overall response of Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR). CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours
Analysis population: All treated participants
Groups in this outcome
Cohort A
(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
Cohort B
(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
Cohort C
(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
| Group | Source count |
|---|---|
| Cohort A | 56 |
| Cohort B | 112 |
| Cohort C | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 32.1 | Not reported | Not reported | Not reported | Not reported |
| Cohort B | 79.5 | Not reported | Not reported | Not reported | Not reported |
| Cohort C | 94.4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 32.1
- group Id
- OG001
- value
- 79.5
- group Id
- OG002
- value
- 94.4
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 112
- group Id
- OG002
- value
- 18
- units
- Participants
- description
- ORR per Modified International Myeloma Working Group (mIMWG) Criteria is defined as the percentage of participants who achieve best overall response of Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR). CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours
- groups
- description
- (Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
- id
- OG000
- title
- Cohort A
- description
- (Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
- id
- OG001
- title
- Cohort B
- description
- (Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
- id
- OG002
- title
- Cohort C
- param Type
- NUMBER
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- From first dose until disease progression or end of treatment whichever occurs first (Up to 130 months)
- title
- Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice