TriangleNCT00114101 · OUTCOME
Time to Progression
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
- Duration of study (up to 10years)
What was measured
Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progression was defined per the International Myeloma Working Group definition as one more of the following: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * 25 % increase in bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas * Development of hypercalcemia
Groups in this outcome
Lenalidomide Maintenance
Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
Placebo Maintenance
Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
| Group | Source count |
|---|---|
| Lenalidomide Maintenance | 231 |
| Placebo Maintenance | 229 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide Maintenance | 39 | Not reported | 36 | NA | The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment |
| Placebo Maintenance | 21 | Not reported | 18 | 28 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.26
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.53
- group Ids
- OG000
- OG001
- non Inferiority Comment
- This study was designed to have 80% power, with the use of the log-rank test at a one-sided significance level of 0.05, to detect a hazard ratio of 1.4, assuming proportional hazards and an exponential time to event distribution. Under the assumed framework, 309 events were expected. The expected drop out rate before randomization was 15%.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
- p Value
- <0.001
- p Value Comment
- Participants were randomized with the use of a permuted-block design stratified by beta 2 microglobulin, prior use of thalidomide and prior use of lenalidomide. TTP was monitored with the use of a group sequential design for superiority and futility.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.36
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.26
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.53
- group Ids
- OG000
- OG001
- non Inferiority Comment
- This study was designed to have 80% power, with the use of the log-rank test at a one-sided significance level of 0.05, to detect a hazard ratio of 1.4, assuming proportional hazards and an exponential time to event distribution. Under the assumed framework, 309 events were expected. The expected drop out rate before randomization was 15%.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
- p Value
- <0.001
- p Value Comment
- Participants were randomized with the use of a permuted-block design stratified by beta 2 microglobulin, prior use of thalidomide and prior use of lenalidomide. TTP was monitored with the use of a group sequential design for superiority and futility.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.36
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
- group Id
- OG000
- lower Limit
- 36
- upper Limit
- NA
- value
- 39
- group Id
- OG001
- lower Limit
- 18
- upper Limit
- 28
- value
- 21
- denoms
- counts
- group Id
- OG000
- value
- 231
- group Id
- OG001
- value
- 229
- units
- Participants
- description
- Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progression was defined per the International Myeloma Working Group definition as one more of the following: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * 25 % increase in bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas * Development of hypercalcemia
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
- id
- OG000
- title
- Lenalidomide Maintenance
- description
- Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
- id
- OG001
- title
- Placebo Maintenance
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Duration of study (up to 10years)
- title
- Time to Progression
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice