TriangleNCT03859427 · OUTCOME
Percentage of Participants Who Achieved Minimal Residual Disease Negative Complete Response (MRD[-]CR) by Independent Review Committee (IRC) Per 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
MRD\[-\]CR was defined as achievement of CR or better by IRC per IMWG-URC and achievement of MRD negativity as assessed by next generation sequencing method at a 10\^-5 threshold over the duration of the study. The 95% CIs for percentages were estimated using the Clopper-Pearson method.
Analysis population: The 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 | 18.1 | Not reported | 13.3 | 23.8 | Not reported |
| Once-weekly KRd 20/56 mg/m^2 | 21.5 | Not reported | 16.3 | 27.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.775
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.970
- estimate Comment
- Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Odds Ratio (OR)
- param Value
- 1.235
Complete source fields
- analyses
- ci Lower Limit
- 0.775
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.970
- estimate Comment
- Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Odds Ratio (OR)
- param Value
- 1.235
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.3
- upper Limit
- 23.8
- value
- 18.1
- group Id
- OG001
- lower Limit
- 16.3
- upper Limit
- 27.4
- value
- 21.5
- denoms
- counts
- group Id
- OG000
- value
- 226
- group Id
- OG001
- value
- 228
- units
- Participants
- description
- MRD\[-\]CR was defined as achievement of CR or better by IRC per IMWG-URC and achievement of MRD negativity as assessed by next generation sequencing method at a 10\^-5 threshold over the duration of the study. The 95% CIs for percentages 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 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
- Percentage of Participants Who Achieved Minimal Residual Disease Negative Complete Response (MRD[-]CR) by Independent Review Committee (IRC) Per IMWG-URC
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice