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NCT01946477 · BASELINE

Baseline characteristics

Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting · Source last updated 2026-06-15

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
      56
    2. group Id
      BG001
      value
      112
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      186
    units
    Participants
groups
  1. description
    (Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
    id
    BG000
    title
    Cohort A
  2. description
    (Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
    id
    BG001
    title
    Cohort B
  3. description
    (Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
    id
    BG002
    title
    Cohort C
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          77
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          109
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          64
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          122
        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
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          177
        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. group Id
          BG003
          value
          0
        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. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          28
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          138
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        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
      56
    2. group Id
      BG001
      value
      112
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      186
    units
    Participants
groups
  1. description
    (Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
    id
    BG000
    title
    Cohort A
  2. description
    (Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
    id
    BG001
    title
    Cohort B
  3. description
    (Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
    id
    BG002
    title
    Cohort C
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          77
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          109
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          64
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          122
        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
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          177
        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. group Id
          BG003
          value
          0
        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. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          28
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          138
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice