TriangleNCT01946477 · OUTCOME
Time to Progression (TTP)
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 whichever occurs first (Up to 130 months)
What was measured
TTP is defined as the time from start of treatment until Progressive Disease (as determined by the site investigator according to modified International Myeloma Working Group (mIMWG) criteria). Participants not experiencing a documented progression will be censored at the time of their last response assessment. Disease Progression=Increase or reappearance of monoclonal protein in serum or urine meeting mIMWG progression thresholds; Increase in bone marrow plasma cell percentage consistent with disease progression; Development of new or worsening lytic bone lesions; Progressive or newly enlarging extramedullary plasmacytomas. Based on Kaplan-Meier Estimates
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 | 12.2 | Not reported | 7.9 | 28.5 | Not reported |
| Cohort B | 34.5 | Not reported | 23.5 | 57.7 | Not reported |
| Cohort C | NA | Not reported | 18.6 | NA | Insufficient number of participants with events to calculate median and upper limit |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.9
- upper Limit
- 28.5
- value
- 12.2
- group Id
- OG001
- lower Limit
- 23.5
- upper Limit
- 57.7
- value
- 34.5
- comment
- Insufficient number of participants with events to calculate median and upper limit
- group Id
- OG002
- lower Limit
- 18.6
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 112
- group Id
- OG002
- value
- 18
- units
- Participants
- description
- TTP is defined as the time from start of treatment until Progressive Disease (as determined by the site investigator according to modified International Myeloma Working Group (mIMWG) criteria). Participants not experiencing a documented progression will be censored at the time of their last response assessment. Disease Progression=Increase or reappearance of monoclonal protein in serum or urine meeting mIMWG progression thresholds; Increase in bone marrow plasma cell percentage consistent with disease progression; Development of new or worsening lytic bone lesions; Progressive or newly enlarging extramedullary plasmacytomas. 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 treated participants
- reporting Status
- POSTED
- time Frame
- From first dose until the first documented disease progression whichever occurs first (Up to 130 months)
- title
- Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice