TriangleNCT03158688 · OUTCOME
Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More
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
- PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks
What was measured
A measure of the persistence of the CR (includes strict CR) per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and MRD\[-\] status as assessed by next-generation sequencing (NGS; at a 10\^-5 level) for 12 months or more after achieving MRD\[-\]CR status. 95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method.
Analysis population: Intent to Treat Population
Groups in this outcome
Kd - Carfilzomib and Dexamethasone
Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.
KdD - Carfilzomib, Dexamethasone and Daratumumab
Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.
| Group | Source count |
|---|---|
| Kd - Carfilzomib and Dexamethasone | 154 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | 312 |
Reported measurements
PA DCO
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | 0.0 | Not reported | 0.0 | 2.4 | Not reported |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | 0.0 | Not reported | 0.0 | 1.2 | Not reported |
FA DCO
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | 0.0 | Not reported | 0.0 | 2.4 | Not reported |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | 5.8 | Not reported | 3.5 | 9.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 2.4
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 1.2
- value
- 0.0
- title
- PA DCO
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 2.4
- value
- 0.0
- group Id
- OG001
- lower Limit
- 3.5
- upper Limit
- 9.0
- value
- 5.8
- title
- FA DCO
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 312
- units
- Participants
- description
- A measure of the persistence of the CR (includes strict CR) per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and MRD\[-\] status as assessed by next-generation sequencing (NGS; at a 10\^-5 level) for 12 months or more after achieving MRD\[-\]CR status. 95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.
- id
- OG000
- title
- Kd - Carfilzomib and Dexamethasone
- description
- Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.
- id
- OG001
- title
- KdD - Carfilzomib, Dexamethasone and Daratumumab
- param Type
- NUMBER
- population Description
- Intent to Treat Population
- reporting Status
- POSTED
- time Frame
- PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks
- title
- Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice