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NCT02937571 · BASELINE

Baseline characteristics

High Dose Carfilzomib for Newly Diagnosed Myeloma · Source last updated 2025-11-20

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
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      23
    4. group Id
      BG003
      value
      29
    units
    Participants
groups
  1. description
    * Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
    id
    BG000
    title
    Dose Level 1: Carfilzomib 45mg/m2/Dose
  2. description
    * Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
    id
    BG001
    title
    Dose Level 2: Carfilzomib 56mg/m2/Dose
  3. description
    * Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
    id
    BG002
    title
    MTD: Carfilzomib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          60
          upper Limit
          66
          value
          63
        2. group Id
          BG001
          lower Limit
          50
          upper Limit
          71
          value
          68
        3. group Id
          BG002
          lower Limit
          43
          upper Limit
          75
          value
          60
        4. group Id
          BG003
          lower Limit
          43
          upper Limit
          75
          value
          61
    dispersion Type
    FULL_RANGE
    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
          10
        4. group Id
          BG003
          value
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          15
        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
          2
        4. group Id
          BG003
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          27
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Asian
      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
        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
          3
        4. group Id
          BG003
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          21
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          29
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      23
    4. group Id
      BG003
      value
      29
    units
    Participants
groups
  1. description
    * Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
    id
    BG000
    title
    Dose Level 1: Carfilzomib 45mg/m2/Dose
  2. description
    * Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
    id
    BG001
    title
    Dose Level 2: Carfilzomib 56mg/m2/Dose
  3. description
    * Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
    id
    BG002
    title
    MTD: Carfilzomib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          60
          upper Limit
          66
          value
          63
        2. group Id
          BG001
          lower Limit
          50
          upper Limit
          71
          value
          68
        3. group Id
          BG002
          lower Limit
          43
          upper Limit
          75
          value
          60
        4. group Id
          BG003
          lower Limit
          43
          upper Limit
          75
          value
          61
    dispersion Type
    FULL_RANGE
    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
          10
        4. group Id
          BG003
          value
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          15
        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
          2
        4. group Id
          BG003
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          27
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Asian
      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
        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
          3
        4. group Id
          BG003
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          21
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          29
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice