TriangleNCT02036502 · OUTCOME
Overall Survival (OS)
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
- Up to approximately 72.7 months
What was measured
OS was defined as the time from randomization to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Analysis population: The analysis population included all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (rrMM or rMM) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Groups in this outcome
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
Pooled rrMM Cohort
Participants from Parts 1 and 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received any dose combination of pembrolizumab Q2W (Days 1 and 15) in combination with lenalidomide and dexamethasone Q1W during each 28-day cycle.
Pooled rMM Cohort
Participants from Part 2 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
| Group | Source count |
|---|---|
| Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg | 0 |
| Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg | 0 |
| Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg | 0 |
| Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg | 0 |
| Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg | 0 |
| Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg | 0 |
| Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg | 0 |
| Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg | 0 |
| Pooled rrMM Cohort | 63 |
| Pooled rMM Cohort | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pooled rrMM Cohort | 29.0 | Not reported | 17.8 | 42.4 | Not reported |
| Pooled rMM Cohort | 22.5 | Not reported | 2.0 | NA | OS upper limit could not be estimated due to insufficient number of events at the time of final analysis. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG008
- lower Limit
- 17.8
- upper Limit
- 42.4
- value
- 29.0
- comment
- OS upper limit could not be estimated due to insufficient number of events at the time of final analysis.
- group Id
- OG009
- lower Limit
- 2.0
- upper Limit
- NA
- value
- 22.5
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 63
- group Id
- OG009
- value
- 10
- units
- Participants
- description
- OS was defined as the time from randomization to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
- id
- OG000
- title
- Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
- description
- Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG001
- title
- Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
- description
- Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG002
- title
- Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
- description
- Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG003
- title
- Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
- description
- Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG004
- title
- Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
- description
- Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
- id
- OG005
- title
- Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
- description
- Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
- id
- OG006
- title
- Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
- description
- Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
- id
- OG007
- title
- Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
- description
- Participants from Parts 1 and 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received any dose combination of pembrolizumab Q2W (Days 1 and 15) in combination with lenalidomide and dexamethasone Q1W during each 28-day cycle.
- id
- OG008
- title
- Pooled rrMM Cohort
- description
- Participants from Part 2 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
- id
- OG009
- title
- Pooled rMM Cohort
- param Type
- MEDIAN
- population Description
- The analysis population included all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (rrMM or rMM) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
- reporting Status
- POSTED
- time Frame
- Up to approximately 72.7 months
- title
- Overall Survival (OS)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice