TriangleNCT02579863 · OUTCOME
Progression Free Survival (PFS) Evaluated According to the International Myeloma Working Group (IMWG) Response Criteria 2011 by Clinical Adjudication Committee (CAC) Blinded Central Review
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 30 months
What was measured
PFS was defined as the time from randomization to the first documented disease progression (events of new bone lesions, soft tissue plasmacytomas or an increase in existing lesions, or death due to any cause). The median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. Due to the small number of events, the tail of the estimated survival distribution was close to the median for both arms. The higher variability of the tail estimates resulted in observing the median estimate in the experimental arm but not in the standard of care arm even when number of events in 2 arms were similar. The database cutoff date was July 9, 2018.
Analysis population: The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
Groups in this outcome
Pembrolizumab + Lenalidomide + Dexamethasone
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Lenolidomide + Dexamethasone
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
| Group | Source count |
|---|---|
| Pembrolizumab + Lenalidomide + Dexamethasone | 156 |
| Lenolidomide + Dexamethasone | 154 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Lenalidomide + Dexamethasone | 19.6 | Not reported | 15.3 | NA | Upper Limit could not be estimated due to an insufficient number of events by the date of data cutoff. |
| Lenolidomide + Dexamethasone | NA | Not reported | 15.5 | NA | The Median was not reached, and the Upper Limit could not be estimated due to insufficient number of events by the date of data cutoff. |
Source statistical analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.45
- estimate Comment
- Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.33475
- param Type
- Hazard Ratio (HR)
- param Value
- 0.90
- statistical Comment
- One-sided p-value based on Stratified log-rank test.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.45
- estimate Comment
- Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.33475
- param Type
- Hazard Ratio (HR)
- param Value
- 0.90
- statistical Comment
- One-sided p-value based on Stratified log-rank test.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Upper Limit could not be estimated due to an insufficient number of events by the date of data cutoff.
- group Id
- OG000
- lower Limit
- 15.3
- upper Limit
- NA
- value
- 19.6
- comment
- The Median was not reached, and the Upper Limit could not be estimated due to insufficient number of events by the date of data cutoff.
- group Id
- OG001
- lower Limit
- 15.5
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 156
- group Id
- OG001
- value
- 154
- units
- Participants
- description
- PFS was defined as the time from randomization to the first documented disease progression (events of new bone lesions, soft tissue plasmacytomas or an increase in existing lesions, or death due to any cause). The median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. Due to the small number of events, the tail of the estimated survival distribution was close to the median for both arms. The higher variability of the tail estimates resulted in observing the median estimate in the experimental arm but not in the standard of care arm even when number of events in 2 arms were similar. The database cutoff date was July 9, 2018.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
- id
- OG000
- title
- Pembrolizumab + Lenalidomide + Dexamethasone
- description
- Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
- id
- OG001
- title
- Lenolidomide + Dexamethasone
- param Type
- MEDIAN
- population Description
- The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Up to approximately 30 months
- title
- Progression Free Survival (PFS) Evaluated According to the International Myeloma Working Group (IMWG) Response Criteria 2011 by Clinical Adjudication Committee (CAC) Blinded Central Review
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice