TriangleNCT00522392 · OUTCOME
Progression-free Survival (PFS)
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 if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years
What was measured
Progression-free survival was defined as the time from randomization to the earliest documentation of disease progression (PD) or death. If a patient died without evidence of PD, the patient was considered an event if death occurred within 3 months of the last disease assessment. Patients who died outside of the specified interval or patients who were alive without evidence of PD were censored at the date of last disease assessment. The PFS results are based on data as of August 2012, while overall survival (OS) was updated in April 2014. Given the early termination and limited sample size, data management efforts to update PFS were not pursued.
Analysis population: All randomized patients
Groups in this outcome
Arm A (VRD)
Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin. bortezomib: Given IV lenalidomide: Given PO dexamethasone: Given PO
Arm B (VD)
Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. bortezomib: Given IV dexamethasone: Given PO
| Group | Source count |
|---|---|
| Arm A (VRD) | 23 |
| Arm B (VD) | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (VRD) | NA | Not reported | NA | NA | Median PFS was not reached for Arm A (VRD). |
| Arm B (VD) | 17.4 | Not reported | 7.1 | 35.4 | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Description
- Stratified log rank test was used to compare progression-free survival between the two arms.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.092
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Description
- Stratified log rank test was used to compare progression-free survival between the two arms.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.092
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- comment
- Median PFS was not reached for Arm A (VRD).
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 7.1
- upper Limit
- 35.4
- value
- 17.4
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- Progression-free survival was defined as the time from randomization to the earliest documentation of disease progression (PD) or death. If a patient died without evidence of PD, the patient was considered an event if death occurred within 3 months of the last disease assessment. Patients who died outside of the specified interval or patients who were alive without evidence of PD were censored at the date of last disease assessment. The PFS results are based on data as of August 2012, while overall survival (OS) was updated in April 2014. Given the early termination and limited sample size, data management efforts to update PFS were not pursued.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin. bortezomib: Given IV lenalidomide: Given PO dexamethasone: Given PO
- id
- OG000
- title
- Arm A (VRD)
- description
- Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. bortezomib: Given IV dexamethasone: Given PO
- id
- OG001
- title
- Arm B (VD)
- param Type
- MEDIAN
- population Description
- All randomized patients
- reporting Status
- POSTED
- time Frame
- Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice