TriangleNCT01818752 · 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
- From randomization until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
What was measured
Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression. Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner.
Analysis population: The intent-to-treat population included all randomized participants.
Groups in this outcome
Bortezomib, Melphalan, Prednisone
Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
Carfilzomib, Melphalan, Prednisone
Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
| Group | Source count |
|---|---|
| Bortezomib, Melphalan, Prednisone | 477 |
| Carfilzomib, Melphalan, Prednisone | 478 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib, Melphalan, Prednisone | 22.1 | Not reported | 20.8 | 24.4 | Not reported |
| Carfilzomib, Melphalan, Prednisone | 22.3 | Not reported | 20.9 | 26.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.746
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.101
- estimate Comment
- The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.
- group Description
- The inferential test associated with the primary analysis of PFS was assessed against an overall 1-sided significance level of α=0.025.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1590
- p Value Comment
- The p-value boundary for PFS analysis was 0.02141.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.906
- statistical Comment
- Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.746
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.101
- estimate Comment
- The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.
- group Description
- The inferential test associated with the primary analysis of PFS was assessed against an overall 1-sided significance level of α=0.025.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1590
- p Value Comment
- The p-value boundary for PFS analysis was 0.02141.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.906
- statistical Comment
- Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.8
- upper Limit
- 24.4
- value
- 22.1
- group Id
- OG001
- lower Limit
- 20.9
- upper Limit
- 26.7
- value
- 22.3
- denoms
- counts
- group Id
- OG000
- value
- 477
- group Id
- OG001
- value
- 478
- units
- Participants
- description
- Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression. Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
- id
- OG000
- title
- Bortezomib, Melphalan, Prednisone
- description
- Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
- id
- OG001
- title
- Carfilzomib, Melphalan, Prednisone
- param Type
- MEDIAN
- population Description
- The intent-to-treat population included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
- title
- Progression-Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice