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NCT03837509 · BASELINE

Baseline characteristics

INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma · Source last updated 2025-11-04

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
      6
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      2
    6. group Id
      BG005
      value
      15
    units
    Participants
groups
  1. description
    In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
    id
    BG000
    title
    Phase 1: INCB001158 75 mg BID + Daratumumab
  2. description
    In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
    id
    BG001
    title
    Phase 1: INCB001158 100 mg BID + Daratumumab
  3. description
    In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
    id
    BG002
    title
    Phase 2: INCB001158 100 mg BID + Daratumumab
  4. description
    In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
    id
    BG003
    title
    Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab
  5. description
    In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
    id
    BG004
    title
    Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.70
          value
          65.0
        2. group Id
          BG001
          spread
          9.83
          value
          68.0
        3. group Id
          BG002
          spread
          12.73
          value
          67.0
        4. comment
          To protect participant privacy, a mean age and standard deviation are not reported for a single participant.
          group Id
          BG003
          spread
          NA
          value
          NA
        5. group Id
          BG004
          spread
          19.09
          value
          71.5
        6. group Id
          BG005
          spread
          10.59
          value
          67.1
    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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. comment
          To protect participant privacy, sex is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. comment
          To protect participant privacy, sex is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          2
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, ethnicity is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          1
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. comment
          To protect participant privacy, ethnicity is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          1
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, ethnicity is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          2
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      2
    6. group Id
      BG005
      value
      15
    units
    Participants
groups
  1. description
    In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
    id
    BG000
    title
    Phase 1: INCB001158 75 mg BID + Daratumumab
  2. description
    In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
    id
    BG001
    title
    Phase 1: INCB001158 100 mg BID + Daratumumab
  3. description
    In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
    id
    BG002
    title
    Phase 2: INCB001158 100 mg BID + Daratumumab
  4. description
    In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
    id
    BG003
    title
    Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab
  5. description
    In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
    id
    BG004
    title
    Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.70
          value
          65.0
        2. group Id
          BG001
          spread
          9.83
          value
          68.0
        3. group Id
          BG002
          spread
          12.73
          value
          67.0
        4. comment
          To protect participant privacy, a mean age and standard deviation are not reported for a single participant.
          group Id
          BG003
          spread
          NA
          value
          NA
        5. group Id
          BG004
          spread
          19.09
          value
          71.5
        6. group Id
          BG005
          spread
          10.59
          value
          67.1
    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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. comment
          To protect participant privacy, sex is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. comment
          To protect participant privacy, sex is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          2
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, ethnicity is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          1
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. comment
          To protect participant privacy, ethnicity is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          1
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, ethnicity is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          2
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. comment
          To protect participant privacy, race is not reported for a single participant.
          group Id
          BG003
          value
          NA
        5. group Id
          BG004
          value
          0
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        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