Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05405166 · BASELINE

Baseline characteristics

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM · Source last updated 2026-09-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      268
    2. group Id
      BG001
      value
      263
    3. group Id
      BG002
      value
      531
    units
    Participants
groups
  1. description
    Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
    id
    BG000
    title
    Isa-IV + Pd
  2. description
    Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
    id
    BG001
    title
    Isa-SC + Pd
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.7
          value
          64.7
        2. group Id
          BG001
          spread
          9.4
          value
          65.7
        3. group Id
          BG002
          spread
          9.6
          value
          65.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          238
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          137
        3. group Id
          BG002
          value
          293
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          111
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          22
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          184
        2. group Id
          BG001
          value
          184
        3. group Id
          BG002
          value
          368
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          25
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Baseline characteristics were assessed for all randomized population.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      268
    2. group Id
      BG001
      value
      263
    3. group Id
      BG002
      value
      531
    units
    Participants
groups
  1. description
    Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
    id
    BG000
    title
    Isa-IV + Pd
  2. description
    Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
    id
    BG001
    title
    Isa-SC + Pd
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.7
          value
          64.7
        2. group Id
          BG001
          spread
          9.4
          value
          65.7
        3. group Id
          BG002
          spread
          9.6
          value
          65.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          238
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          137
        3. group Id
          BG002
          value
          293
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          111
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          22
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          184
        2. group Id
          BG001
          value
          184
        3. group Id
          BG002
          value
          368
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          25
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Baseline characteristics were assessed for all randomized population.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice