TriangleNCT06055075 · OUTCOME
Investigator-assessed Objective Response Rate (ORR) Per International Myeloma Working Group (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
ORR=percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG response criteria. CR \& sCR are defined as outlined in endpoint 5 (CRR/sCRR). VGPR=serum \& urine M-protein (UMP) detectable by immunofixation, but not electrophoresis; ≥90% reduction in serum M-protein (SMP) + UMP level \<100 mg/24 hrs; at baseline ≥90% reduction in sum of the maximal perpendicular diameter (SPD) compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. PR=≥50% reduction in SMP \& UMP reduction ≥90% or \<200 mg/24hours; if SMP \& UMP not measurable, ≥50% decrease in involved \& uninvolved SFLC difference in place of M-protein criteria; if SMP, UMP \& SFLC assay not unmeasurable, ≥50% reduction in plasma cells required in place of M-protein (baseline BM plasma cell ≥30%); at baseline, a ≥50% reduction in SPD of soft tissue plasmacytomas.
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 | 83.3 | Not reported | 35.88 | 99.58 | 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
- 35.88
- upper Limit
- 99.58
- value
- 83.3
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- ORR=percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG response criteria. CR \& sCR are defined as outlined in endpoint 5 (CRR/sCRR). VGPR=serum \& urine M-protein (UMP) detectable by immunofixation, but not electrophoresis; ≥90% reduction in serum M-protein (SMP) + UMP level \<100 mg/24 hrs; at baseline ≥90% reduction in sum of the maximal perpendicular diameter (SPD) compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. PR=≥50% reduction in SMP \& UMP reduction ≥90% or \<200 mg/24hours; if SMP \& UMP not measurable, ≥50% decrease in involved \& uninvolved SFLC difference in place of M-protein criteria; if SMP, UMP \& SFLC assay not unmeasurable, ≥50% reduction in plasma cells required in place of M-protein (baseline BM plasma cell ≥30%); at baseline, a ≥50% reduction in SPD of soft tissue plasmacytomas.
- 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 Objective Response Rate (ORR) Per International Myeloma Working Group (IMWG) Response Criteria
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice