TriangleNCT06055075 · OUTCOME
Investigator-assessed VGPR Rate or Better Per IMWG Response Criteria
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
- Up to approximately 15.2 months
What was measured
VGPR rate was defined as the percentage of participants with VGPR as determined by the investigator per IMWG response criteria. VGPR was defined as: serum \& UMP detectable by immunofixation, but not on electrophoresis; or ≥90% reduction in SMP plus UMP level \<100 mg/24 hours; at baseline ≥90% reduction in SPD compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. Responses better than VGPR include CR and sCR (as defined in endpoint 5). Percentages have been rounded off.
Analysis population: Efficacy-evaluable population included all response evaluable participants, i.e., those who received at least one dose of one of their assigned study treatments and had at least one baseline and one on-treatment tumor assessment or those who had one tumor assessment at baseline and discontinued their treatment for any reason before their first on-treatment tumor assessment.
Groups in this outcome
Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib
Participants received step-up doses of forimtamig 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.3 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib
Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.75 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib
Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 1.5 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
| Group | Source count |
|---|---|
| Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib | 7 |
| Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib | 6 |
| Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib | 85.7 | Not reported | 42.13 | 99.64 | Not reported |
| Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib | 83.3 | Not reported | 35.88 | 99.58 | Not reported |
| Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib | 50.0 | Not reported | 11.81 | 88.19 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 42.13
- upper Limit
- 99.64
- value
- 85.7
- group Id
- OG001
- lower Limit
- 35.88
- upper Limit
- 99.58
- value
- 83.3
- group Id
- OG002
- lower Limit
- 11.81
- upper Limit
- 88.19
- value
- 50.0
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- VGPR rate was defined as the percentage of participants with VGPR as determined by the investigator per IMWG response criteria. VGPR was defined as: serum \& UMP detectable by immunofixation, but not on electrophoresis; or ≥90% reduction in SMP plus UMP level \<100 mg/24 hours; at baseline ≥90% reduction in SPD compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. Responses better than VGPR include CR and sCR (as defined in endpoint 5). Percentages have been rounded off.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received step-up doses of forimtamig 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.3 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
- id
- OG000
- title
- Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib
- description
- Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.75 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
- id
- OG001
- title
- Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib
- description
- Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 1.5 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
- id
- OG002
- title
- Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib
- param Type
- NUMBER
- population Description
- Efficacy-evaluable population included all response evaluable participants, i.e., those who received at least one dose of one of their assigned study treatments and had at least one baseline and one on-treatment tumor assessment or those who had one tumor assessment at baseline and discontinued their treatment for any reason before their first on-treatment tumor assessment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 15.2 months
- title
- Investigator-assessed VGPR Rate or Better Per IMWG Response Criteria
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice