TriangleNCT00602641 · OUTCOME
Overall Survival
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
- Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
What was measured
Overall survival was defined as time from randomization to death from any cause.
Analysis population: Intention-to-treatment (ITT) population
Groups in this outcome
Arm I (MPT-T)
Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.
Arm II (mPR-R)
Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
| Group | Source count |
|---|---|
| Arm I (MPT-T) | 154 |
| Arm II (mPR-R) | 152 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (MPT-T) | 52.6 | Not reported | 40.4 | NA | Upper limit of the confidence interval has not been reached. |
| Arm II (mPR-R) | 47.7 | Not reported | 41.0 | 56.4 | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.476
- statistical Comment
- Analysis was based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y).
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.476
- statistical Comment
- Analysis was based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y).
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Upper limit of the confidence interval has not been reached.
- group Id
- OG000
- lower Limit
- 40.4
- upper Limit
- NA
- value
- 52.6
- group Id
- OG001
- lower Limit
- 41.0
- upper Limit
- 56.4
- value
- 47.7
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 152
- units
- Participants
- description
- Overall survival was defined as time from randomization to death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.
- id
- OG000
- title
- Arm I (MPT-T)
- description
- Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
- id
- OG001
- title
- Arm II (mPR-R)
- param Type
- MEDIAN
- population Description
- Intention-to-treatment (ITT) population
- reporting Status
- POSTED
- time Frame
- Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice