TriangleNCT04191616 · OUTCOME
Number of Participants With Sustained MRD[-]CR for at Least 12 Months as Assessed by the IRC
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 cycle 1 to month 12 (8 to 13 month window)
What was measured
MRD\[-\]CR at the 12 months landmark was defined as achievement of CR (including sCR or better) per IMWG-URC by IRC and MRD\[-\] status at a sensitivity of 10\^-5 using NGS based method in the bone marrow at the 12 months landmark (from 8 months to 13 months window). Maintaining MRD\[-\]CR for at least 12 months (- 4 weeks) was considered as sustained.
Analysis population: The safety analysis set included all participants who received at least 1 dose of carfilzomib.
Groups in this outcome
Carfilzomib With Pomalidomide and Dexamethasone (KPd)
Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.
| Group | Source count |
|---|---|
| Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 52 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 52
- units
- Participants
- description
- MRD\[-\]CR at the 12 months landmark was defined as achievement of CR (including sCR or better) per IMWG-URC by IRC and MRD\[-\] status at a sensitivity of 10\^-5 using NGS based method in the bone marrow at the 12 months landmark (from 8 months to 13 months window). Maintaining MRD\[-\]CR for at least 12 months (- 4 weeks) was considered as sustained.
- groups
- description
- Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.
- id
- OG000
- title
- Carfilzomib With Pomalidomide and Dexamethasone (KPd)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set included all participants who received at least 1 dose of carfilzomib.
- reporting Status
- POSTED
- time Frame
- Day 1 cycle 1 to month 12 (8 to 13 month window)
- title
- Number of Participants With Sustained MRD[-]CR for at Least 12 Months as Assessed by the IRC
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice