NCT05090566 · 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
- 6
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 12
- group Id
- BG006
- value
- 46
- units
- Participants
- groups
- description
- Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
- id
- BG000
- title
- SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1
- description
- Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
- id
- BG001
- title
- SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2
- description
- Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
- id
- BG002
- title
- SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3
- description
- Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.
- id
- BG003
- title
- SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A
- description
- Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.
- id
- BG004
- title
- SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A
- description
- Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and 44 mg on Cycle 0 Day 8 and thereafter 44 mg weekly during each cycle (1 cycle = 4 weeks) and Lenalidomide 15 mg QD for 21 days and Dexamethasone 20 mg weekly on Cycle 1 and 2.
- id
- BG005
- title
- SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1
- description
- Total of all reporting groups
- id
- BG006
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 2.83
- value
- 61.00
- group Id
- BG001
- spread
- 9.58
- value
- 54.67
- group Id
- BG002
- spread
- 10.17
- value
- 67.50
- group Id
- BG003
- spread
- 8.83
- value
- 69.60
- group Id
- BG004
- spread
- 9.43
- value
- 67.83
- group Id
- BG005
- spread
- 8.49
- value
- 66.33
- group Id
- BG006
- spread
- 9.81
- value
- 65.74
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 4
- group Id
- BG006
- value
- 15
- title
- Female
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 8
- group Id
- BG006
- value
- 31
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 9
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 9
- group Id
- BG006
- value
- 37
- 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
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- 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
- 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
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- 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
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 5
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 39
- 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
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 2
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 12
- group Id
- BG006
- value
- 46
- units
- Participants
- groups
- description
- Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
- id
- BG000
- title
- SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1
- description
- Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
- id
- BG001
- title
- SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2
- description
- Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
- id
- BG002
- title
- SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3
- description
- Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.
- id
- BG003
- title
- SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A
- description
- Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.
- id
- BG004
- title
- SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A
- description
- Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and 44 mg on Cycle 0 Day 8 and thereafter 44 mg weekly during each cycle (1 cycle = 4 weeks) and Lenalidomide 15 mg QD for 21 days and Dexamethasone 20 mg weekly on Cycle 1 and 2.
- id
- BG005
- title
- SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1
- description
- Total of all reporting groups
- id
- BG006
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 2.83
- value
- 61.00
- group Id
- BG001
- spread
- 9.58
- value
- 54.67
- group Id
- BG002
- spread
- 10.17
- value
- 67.50
- group Id
- BG003
- spread
- 8.83
- value
- 69.60
- group Id
- BG004
- spread
- 9.43
- value
- 67.83
- group Id
- BG005
- spread
- 8.49
- value
- 66.33
- group Id
- BG006
- spread
- 9.81
- value
- 65.74
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 4
- group Id
- BG006
- value
- 15
- title
- Female
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 8
- group Id
- BG006
- value
- 31
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 9
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 9
- group Id
- BG006
- value
- 37
- 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
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- 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
- 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
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- 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
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 5
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 39
- 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
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 2
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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