TriangleNCT02579863 · OUTCOME
Duration of Response (DOR) Evaluated According to IMWG Response Criteria by 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
Response duration was defined as the time from first documented evidence of at least a partial response (sCR+CR+VGPR+PR\]), until confirmed disease progression or death. DOR was calculated from product-limit (Kaplan-Meier) method for censored data. This is an event-driven (events of disease progression and death) outcome measure. At the time of data cut-off, there were an insufficient number of events from the censored data to be able to estimate certain parameters (e.g. medians). Full Range is the minimum and maximum of the observed duration of response. The data cutoff date was July 9, 2018.
Analysis population: The analysis population included all randomized participants who demonstrated at least a partial response. 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 | 116 |
| Lenolidomide + Dexamethasone | 106 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Lenalidomide + Dexamethasone | NA | Not reported | NA | NA | The Median was not reached, and the limits could not be estimated due to the lack of progressive disease by the time of last disease assessment. |
| Lenolidomide + Dexamethasone | NA | Not reported | NA | NA | The Median was not reached, and the limits could not be estimated due to the lack of progressive disease by the time of last disease assessment. |
Complete source fields
- classes
- categories
- measurements
- comment
- The Median was not reached, and the limits could not be estimated due to the lack of progressive disease by the time of last disease assessment.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The Median was not reached, and the limits could not be estimated due to the lack of progressive disease by the time of last disease assessment.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 116
- group Id
- OG001
- value
- 106
- units
- Participants
- description
- Response duration was defined as the time from first documented evidence of at least a partial response (sCR+CR+VGPR+PR\]), until confirmed disease progression or death. DOR was calculated from product-limit (Kaplan-Meier) method for censored data. This is an event-driven (events of disease progression and death) outcome measure. At the time of data cut-off, there were an insufficient number of events from the censored data to be able to estimate certain parameters (e.g. medians). Full Range is the minimum and maximum of the observed duration of response. The data 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 who demonstrated at least a partial response. Participants were included in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Up to approximately 30 months
- title
- Duration of Response (DOR) Evaluated According to IMWG Response Criteria by CAC Blinded Central Review
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice