NCT06055075 · OUTCOME
Maximum Observed Concentration (Cmax) of Forimtamig
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 of Cycle 3 (1 cycle=28 days)
Analysis population: PK-evaluable population included all participants in the safety population who had PK data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis.
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 | 4 |
| Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib | 4 |
| Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib | 31.7 | 51.2 | Not reported | Not reported | Not reported |
| Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib | 57.7 | 95.0 | Not reported | Not reported | Not reported |
| Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib | 89.6 | 263 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 51.2
- value
- 31.7
- group Id
- OG001
- spread
- 95.0
- value
- 57.7
- group Id
- OG002
- spread
- 263
- value
- 89.6
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- 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
- GEOMETRIC_MEAN
- population Description
- PK-evaluable population included all participants in the safety population who had PK data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 3 (1 cycle=28 days)
- title
- Maximum Observed Concentration (Cmax) of Forimtamig
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice
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