NCT06055075 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 21
- units
- Participants
- 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
- BG000
- 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
- BG001
- 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
- BG002
- title
- Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 12
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 9
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 8
- title
- Female
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 13
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 16
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 5
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 5
- title
- Asian
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 12
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- Data for all participants randomized in the study have been presented.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 21
- units
- Participants
- 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
- BG000
- 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
- BG001
- 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
- BG002
- title
- Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 12
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 9
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 8
- title
- Female
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 13
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 16
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 5
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 5
- title
- Asian
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 12
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- Data for all participants randomized in the study have been presented.
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice
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