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NCT03859427 · BASELINE

Baseline characteristics

A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-08-13

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
      226
    2. group Id
      BG001
      value
      228
    3. group Id
      BG002
      value
      454
    units
    Participants
groups
  1. description
    Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
    id
    BG000
    title
    Twice-weekly KRd 20/27 mg/m^2
  2. description
    Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
    id
    BG001
    title
    Once-weekly KRd 20/56 mg/m^2
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.2
          value
          64.0
        2. group Id
          BG001
          spread
          8.4
          value
          63.7
        3. group Id
          BG002
          spread
          8.3
          value
          63.8
    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
          100
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          218
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          236
        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
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          428
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          209
        2. group Id
          BG001
          value
          209
        3. group Id
          BG002
          value
          418
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          201
        2. group Id
          BG001
          value
          201
        3. group Id
          BG002
          value
          402
        title
        Stage 1 or 2
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          52
        title
        Stage 3
    description
    ISS stage classification at study entry per interactive voice/web response system for randomization. Stage 1: serum beta-2 microglobulin \< 3.5 mg/L and serum albumin ≥ 3.5 g/dL; Stage 2: serum beta-2 microglobulin \< 3.5 mg/L and serum albumin \< 3.5 g/dL or serum beta-2 microglobulin 3.5 - \< 5.5 mg/L irrespective of the serum albumin; Stage 3: serum beta-2 microglobulin ≥ 5.5 mg/L.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Original ISS Stage at Study Entry
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          164
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          290
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Lenalidomide Treatment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          218
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          432
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          22
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Proteasome Inhibitor Treatment
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          38
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          209
        2. group Id
          BG001
          value
          207
        3. group Id
          BG002
          value
          416
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Anti-CD38 Treatment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      226
    2. group Id
      BG001
      value
      228
    3. group Id
      BG002
      value
      454
    units
    Participants
groups
  1. description
    Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
    id
    BG000
    title
    Twice-weekly KRd 20/27 mg/m^2
  2. description
    Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
    id
    BG001
    title
    Once-weekly KRd 20/56 mg/m^2
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.2
          value
          64.0
        2. group Id
          BG001
          spread
          8.4
          value
          63.7
        3. group Id
          BG002
          spread
          8.3
          value
          63.8
    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
          100
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          218
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          236
        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
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          428
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          209
        2. group Id
          BG001
          value
          209
        3. group Id
          BG002
          value
          418
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          201
        2. group Id
          BG001
          value
          201
        3. group Id
          BG002
          value
          402
        title
        Stage 1 or 2
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          52
        title
        Stage 3
    description
    ISS stage classification at study entry per interactive voice/web response system for randomization. Stage 1: serum beta-2 microglobulin \< 3.5 mg/L and serum albumin ≥ 3.5 g/dL; Stage 2: serum beta-2 microglobulin \< 3.5 mg/L and serum albumin \< 3.5 g/dL or serum beta-2 microglobulin 3.5 - \< 5.5 mg/L irrespective of the serum albumin; Stage 3: serum beta-2 microglobulin ≥ 5.5 mg/L.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Original ISS Stage at Study Entry
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          164
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          290
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Lenalidomide Treatment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          218
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          432
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          22
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Proteasome Inhibitor Treatment
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          38
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          209
        2. group Id
          BG001
          value
          207
        3. group Id
          BG002
          value
          416
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Anti-CD38 Treatment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice