TriangleNCT06055075 · OUTCOME
Area Under the Concentration-time Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of Forimtamig
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanograms*hour/milliliter (ng*hr/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Up to Day 15 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 | 9060 | 34.5 | Not reported | Not reported | Not reported |
| Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib | 13600 | 92.9 | Not reported | Not reported | Not reported |
| Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib | 29500 | 348 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 34.5
- value
- 9060
- group Id
- OG001
- spread
- 92.9
- value
- 13600
- group Id
- OG002
- spread
- 348
- value
- 29500
- 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
- Up to Day 15 of Cycle 3 (1 cycle=28 days)
- title
- Area Under the Concentration-time Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of Forimtamig
- type
- SECONDARY
- unit Of Measure
- nanograms*hour/milliliter (ng*hr/mL)
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Preserved source evidence · Not medical advice