TriangleNCT01946477 · OUTCOME
Duration of Response (DoR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first dose until the first documented disease progression, or death whichever occurs first (Up to 130 months)
What was measured
DoR is defined as thr time from the initial documented response (partial response or better) to the first confirmed progressive disease or until death from any cause. Participants without documented progression will be censored at the time of their last response assessment. 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. Based on Kaplan-Meier Estimates
Analysis population: All responders (PR, VGPR, CR)
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 | 18 |
| Cohort B | 89 |
| Cohort C | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 30.2 | Not reported | 6.8 | NA | Insufficient number of participants with event to calculate upper limit |
| Cohort B | 35.3 | Not reported | 22.4 | 52.5 | Not reported |
| Cohort C | NA | Not reported | 26.3 | NA | Insufficient number of participants with event to calculate upper limit and median |
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient number of participants with event to calculate upper limit
- group Id
- OG000
- lower Limit
- 6.8
- upper Limit
- NA
- value
- 30.2
- group Id
- OG001
- lower Limit
- 22.4
- upper Limit
- 52.5
- value
- 35.3
- comment
- Insufficient number of participants with event to calculate upper limit and median
- group Id
- OG002
- lower Limit
- 26.3
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 89
- group Id
- OG002
- value
- 17
- units
- Participants
- description
- DoR is defined as thr time from the initial documented response (partial response or better) to the first confirmed progressive disease or until death from any cause. Participants without documented progression will be censored at the time of their last response assessment. 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. Based on Kaplan-Meier Estimates
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- All responders (PR, VGPR, CR)
- reporting Status
- POSTED
- time Frame
- From first dose until the first documented disease progression, or death whichever occurs first (Up to 130 months)
- title
- Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice