TriangleNCT03934684 · OUTCOME
Overall Response Rate (ORR) as 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
- From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
What was measured
ORR was defined as the percentage of participants for whom the best overall response was a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the 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% CIs were estimated using the Clopper-Pearson method.
Analysis population: Safety analysis set included all enrolled participants who received at least one dose of IP.
Groups in this outcome
Carfilzomib, Lenalidomide and Dexamethasone (KRd)
Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.
Carfilzomib and Dexamethasone (Kd)
Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
| Group | Source count |
|---|---|
| Carfilzomib, Lenalidomide and Dexamethasone (KRd) | 49 |
| Carfilzomib and Dexamethasone (Kd) | 52 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib, Lenalidomide and Dexamethasone (KRd) | 59.2 | Not reported | 44.2 | 73.0 | Not reported |
| Carfilzomib and Dexamethasone (Kd) | 53.8 | Not reported | 39.5 | 67.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 44.2
- upper Limit
- 73.0
- value
- 59.2
- group Id
- OG001
- lower Limit
- 39.5
- upper Limit
- 67.8
- value
- 53.8
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 52
- units
- Participants
- description
- ORR was defined as the percentage of participants for whom the best overall response was a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the 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% CIs were estimated using the Clopper-Pearson method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.
- id
- OG000
- title
- Carfilzomib, Lenalidomide and Dexamethasone (KRd)
- description
- Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
- id
- OG001
- title
- Carfilzomib and Dexamethasone (Kd)
- param Type
- NUMBER
- population Description
- Safety analysis set included all enrolled participants who received at least one dose of IP.
- reporting Status
- POSTED
- time Frame
- From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
- title
- Overall Response Rate (ORR) as Per IMWG-URC
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice