TriangleNCT00833833 · OUTCOME
Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to 70 weeks
What was measured
Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment. Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome.
Analysis population: Responders (participants with a complete response or partial response) from the ITT population. Data collection is ongoing and future data results will be included as available.
Groups in this outcome
Phase 2: Pomalidomide + Dexamethasone
Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
Phase 2: Pomalidomide
4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
| Group | Source count |
|---|---|
| Phase 2: Pomalidomide + Dexamethasone | 34 |
| Phase 2: Pomalidomide | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Pomalidomide + Dexamethasone | 32.1 | Not reported | 22.1 | 39.9 | Not reported |
| Phase 2: Pomalidomide | NA | Not reported | NA | NA | Not estimable since 9 or 10 responders were censored. The median was not reached at the time of the data cut-off. |
Source statistical analyses
- ci Lower Limit
- 0.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 46.66
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Cox Proportional Hazard
- param Value
- 6.25
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 46.66
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Cox Proportional Hazard
- param Value
- 6.25
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22.1
- upper Limit
- 39.9
- value
- 32.1
- comment
- Not estimable since 9 or 10 responders were censored. The median was not reached at the time of the data cut-off.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment. Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
- id
- OG000
- title
- Phase 2: Pomalidomide + Dexamethasone
- description
- 4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
- id
- OG001
- title
- Phase 2: Pomalidomide
- param Type
- MEDIAN
- population Description
- Responders (participants with a complete response or partial response) from the ITT population. Data collection is ongoing and future data results will be included as available.
- reporting Status
- POSTED
- time Frame
- up to 70 weeks
- title
- Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off
- type
- SECONDARY
- unit Of Measure
- weeks
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Preserved source evidence · Not medical advice