TriangleNCT00424047 · OUTCOME
Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
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
- From randomization up to cut-off date of 02 March 2008; up to 51 months
What was measured
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Analysis population: Intent to treat included all participants who were randomized.
Groups in this outcome
Lenalidomide Plus Dexamethasone
Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
Placebo Plus Dexamethasone
Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.
| Group | Source count |
|---|---|
| Lenalidomide Plus Dexamethasone | 176 |
| Placebo Plus Dexamethasone | 175 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide Plus Dexamethasone | 52.4 | Not reported | 40.9 | 85.6 | Not reported |
| Placebo Plus Dexamethasone | 20.1 | Not reported | 16.6 | 20.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.27
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.478
- estimate Comment
- Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.362
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.27
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.478
- estimate Comment
- Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.362
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 40.9
- upper Limit
- 85.6
- value
- 52.4
- group Id
- OG001
- lower Limit
- 16.6
- upper Limit
- 20.7
- value
- 20.1
- denoms
- counts
- group Id
- OG000
- value
- 176
- group Id
- OG001
- value
- 175
- units
- Participants
- description
- Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
- id
- OG000
- title
- Lenalidomide Plus Dexamethasone
- description
- Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.
- id
- OG001
- title
- Placebo Plus Dexamethasone
- param Type
- MEDIAN
- population Description
- Intent to treat included all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- From randomization up to cut-off date of 02 March 2008; up to 51 months
- title
- Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
- type
- PRIMARY
- unit Of Measure
- weeks
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Preserved source evidence · Not medical advice