TriangleNCT03859427 · OUTCOME
Overall Response Rate (ORR) Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.
What was measured
ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to \< 200 mg/24-hours. The ORR 95% confidence intervals (CIs) were estimated using the Clopper-Pearson method.
Analysis population: The intent-to-treat (ITT) population included all randomized participants.
Groups in this outcome
Twice-weekly KRd 20/27 mg/m^2
Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
Once-weekly KRd 20/56 mg/m^2
Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
| Group | Source count |
|---|---|
| Twice-weekly KRd 20/27 mg/m^2 | 226 |
| Once-weekly KRd 20/56 mg/m^2 | 228 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Twice-weekly KRd 20/27 mg/m^2 | 86.3 | Not reported | 81.1 | 90.5 | Not reported |
| Once-weekly KRd 20/56 mg/m^2 | 82.5 | Not reported | 76.9 | 87.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.882
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.032
- estimate Comment
- Risk ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The non-inferiority margin was 0.87 for the estimated ORR risk ratio.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- 0.0666
- p Value Comment
- P-value (2.5% significance level) of the non-inferiority test via the synthesis approach (FDA, 2016) for non-inferiority comparison of ORR between treatment arms.
- param Type
- Risk Ratio (RR)
- param Value
- 0.954
- statistical Method
- Synthesis approach
Complete source fields
- analyses
- ci Lower Limit
- 0.882
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.032
- estimate Comment
- Risk ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The non-inferiority margin was 0.87 for the estimated ORR risk ratio.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- 0.0666
- p Value Comment
- P-value (2.5% significance level) of the non-inferiority test via the synthesis approach (FDA, 2016) for non-inferiority comparison of ORR between treatment arms.
- param Type
- Risk Ratio (RR)
- param Value
- 0.954
- statistical Method
- Synthesis approach
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 81.1
- upper Limit
- 90.5
- value
- 86.3
- group Id
- OG001
- lower Limit
- 76.9
- upper Limit
- 87.2
- value
- 82.5
- denoms
- counts
- group Id
- OG000
- value
- 226
- group Id
- OG001
- value
- 228
- units
- Participants
- description
- ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to \< 200 mg/24-hours. The ORR 95% confidence intervals (CIs) were estimated using the Clopper-Pearson method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
- id
- OG000
- title
- Twice-weekly KRd 20/27 mg/m^2
- description
- Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
- id
- OG001
- title
- Once-weekly KRd 20/56 mg/m^2
- param Type
- NUMBER
- population Description
- The intent-to-treat (ITT) population included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.
- title
- Overall Response Rate (ORR) Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice