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NCT04191616 · BASELINE

Baseline characteristics

Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet · Source last updated 2025-09-04

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
      52
    units
    Participants
groups
  1. description
    Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.
    id
    BG000
    title
    Carfilzomib With Pomalidomide and Dexamethasone (KPd)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          66.2
    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
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        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
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          45
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        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
          1
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          47
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline measures are presented for the safety analysis set which included participants who received at least 1 dose of carfilzomib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      52
    units
    Participants
groups
  1. description
    Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.
    id
    BG000
    title
    Carfilzomib With Pomalidomide and Dexamethasone (KPd)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          66.2
    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
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        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
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          45
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        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
          1
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          47
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline measures are presented for the safety analysis set which included participants who received at least 1 dose of carfilzomib.

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Preserved source evidence · Not medical advice