NCT03582033 · 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
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 22
- group Id
- BG005
- value
- 20
- group Id
- BG006
- value
- 12
- group Id
- BG007
- value
- 6
- group Id
- BG008
- value
- 5
- group Id
- BG009
- value
- 5
- group Id
- BG010
- value
- 83
- units
- Participants
- groups
- description
- Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG000
- title
- Part A: SEA-BCMA 100mg
- description
- Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG001
- title
- Part A: SEA-BCMA 200mg
- description
- Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG002
- title
- Part A: SEA-BCMA 400mg
- description
- Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG003
- title
- Part A: SEA-BCMA 800mg
- description
- Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG004
- title
- Part A: SEA-BCMA 1600mg
- description
- Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG005
- title
- Part B: SEA-BCMA 1600mg
- description
- Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG006
- title
- Part C: SEA-BCMA 1600mg and Dexamethasone
- description
- Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG007
- title
- Part C: SEA-BCMA 800mg and Dexamethasone
- description
- Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG008
- title
- Part C: SEA-BCMA 1600 mg and Dexamethasone
- description
- Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG009
- title
- Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
- description
- Total of all reporting groups
- id
- BG010
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 2.1
- value
- 68.5
- group Id
- BG001
- spread
- 7.1
- value
- 70.0
- group Id
- BG002
- spread
- 9.2
- value
- 72.5
- group Id
- BG003
- spread
- 10.6
- value
- 64.3
- group Id
- BG004
- spread
- 7.9
- value
- 73.3
- group Id
- BG005
- spread
- 8.9
- value
- 73.2
- group Id
- BG006
- spread
- 8.5
- value
- 66.9
- group Id
- BG007
- spread
- 6.5
- value
- 74.3
- group Id
- BG008
- spread
- 3.9
- value
- 72.6
- group Id
- BG009
- spread
- 6.6
- value
- 71.2
- group Id
- BG010
- spread
- 8.3
- value
- 71.3
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 7
- group Id
- BG006
- value
- 7
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 2
- group Id
- BG009
- value
- 2
- group Id
- BG010
- value
- 36
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 12
- group Id
- BG005
- value
- 13
- group Id
- BG006
- value
- 5
- group Id
- BG007
- value
- 4
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 3
- group Id
- BG010
- value
- 47
- 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
- 1
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 1
- group Id
- BG008
- value
- 1
- group Id
- BG009
- value
- 1
- group Id
- BG010
- value
- 9
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 18
- group Id
- BG005
- value
- 19
- group Id
- BG006
- value
- 10
- group Id
- BG007
- value
- 5
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 72
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- 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
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 1
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 13
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 19
- group Id
- BG005
- value
- 17
- group Id
- BG006
- value
- 9
- group Id
- BG007
- value
- 6
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 5
- group Id
- BG010
- value
- 66
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 1
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 22
- group Id
- BG005
- value
- 20
- group Id
- BG006
- value
- 12
- group Id
- BG007
- value
- 6
- group Id
- BG008
- value
- 5
- group Id
- BG009
- value
- 5
- group Id
- BG010
- value
- 83
- units
- Participants
- groups
- description
- Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG000
- title
- Part A: SEA-BCMA 100mg
- description
- Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG001
- title
- Part A: SEA-BCMA 200mg
- description
- Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG002
- title
- Part A: SEA-BCMA 400mg
- description
- Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG003
- title
- Part A: SEA-BCMA 800mg
- description
- Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG004
- title
- Part A: SEA-BCMA 1600mg
- description
- Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG005
- title
- Part B: SEA-BCMA 1600mg
- description
- Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG006
- title
- Part C: SEA-BCMA 1600mg and Dexamethasone
- description
- Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG007
- title
- Part C: SEA-BCMA 800mg and Dexamethasone
- description
- Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG008
- title
- Part C: SEA-BCMA 1600 mg and Dexamethasone
- description
- Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- BG009
- title
- Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
- description
- Total of all reporting groups
- id
- BG010
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 2.1
- value
- 68.5
- group Id
- BG001
- spread
- 7.1
- value
- 70.0
- group Id
- BG002
- spread
- 9.2
- value
- 72.5
- group Id
- BG003
- spread
- 10.6
- value
- 64.3
- group Id
- BG004
- spread
- 7.9
- value
- 73.3
- group Id
- BG005
- spread
- 8.9
- value
- 73.2
- group Id
- BG006
- spread
- 8.5
- value
- 66.9
- group Id
- BG007
- spread
- 6.5
- value
- 74.3
- group Id
- BG008
- spread
- 3.9
- value
- 72.6
- group Id
- BG009
- spread
- 6.6
- value
- 71.2
- group Id
- BG010
- spread
- 8.3
- value
- 71.3
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 7
- group Id
- BG006
- value
- 7
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 2
- group Id
- BG009
- value
- 2
- group Id
- BG010
- value
- 36
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 12
- group Id
- BG005
- value
- 13
- group Id
- BG006
- value
- 5
- group Id
- BG007
- value
- 4
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 3
- group Id
- BG010
- value
- 47
- 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
- 1
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 1
- group Id
- BG008
- value
- 1
- group Id
- BG009
- value
- 1
- group Id
- BG010
- value
- 9
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 18
- group Id
- BG005
- value
- 19
- group Id
- BG006
- value
- 10
- group Id
- BG007
- value
- 5
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 72
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- 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
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 1
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 13
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 19
- group Id
- BG005
- value
- 17
- group Id
- BG006
- value
- 9
- group Id
- BG007
- value
- 6
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 5
- group Id
- BG010
- value
- 66
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 1
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle