Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01080391 · BASELINE

Baseline characteristics

Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma · Source last updated 2022-09-21

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
      396
    2. group Id
      BG001
      value
      396
    3. group Id
      BG002
      value
      792
    units
    Participants
groups
  1. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
    id
    BG000
    title
    Lenalidomide and Dexamethasone (Rd)
  2. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
    id
    BG001
    title
    Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.04
          value
          64.5
        2. group Id
          BG001
          spread
          9.21
          value
          63.3
        3. group Id
          BG002
          spread
          9.14
          value
          63.9
    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
          164
        2. group Id
          BG001
          value
          181
        3. group Id
          BG002
          value
          345
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          232
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          447
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Asian/Native Hawaiian or Pacific Islander
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          23
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          377
        2. group Id
          BG001
          value
          377
        3. group Id
          BG002
          value
          754
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          154
        title
        < 2.5 mg/L
      2. measurements
        1. group Id
          BG000
          value
          319
        2. group Id
          BG001
          value
          319
        3. group Id
          BG002
          value
          638
        title
        ≥ 2.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum β2 Microglobulin
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          261
        3. group Id
          BG002
          value
          522
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          270
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Bortezomib Exposure
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          158
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          318
        2. group Id
          BG001
          value
          316
        3. group Id
          BG002
          value
          634
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Lenalidomide Exposure
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      396
    2. group Id
      BG001
      value
      396
    3. group Id
      BG002
      value
      792
    units
    Participants
groups
  1. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
    id
    BG000
    title
    Lenalidomide and Dexamethasone (Rd)
  2. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
    id
    BG001
    title
    Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.04
          value
          64.5
        2. group Id
          BG001
          spread
          9.21
          value
          63.3
        3. group Id
          BG002
          spread
          9.14
          value
          63.9
    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
          164
        2. group Id
          BG001
          value
          181
        3. group Id
          BG002
          value
          345
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          232
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          447
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Asian/Native Hawaiian or Pacific Islander
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          23
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          377
        2. group Id
          BG001
          value
          377
        3. group Id
          BG002
          value
          754
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          154
        title
        < 2.5 mg/L
      2. measurements
        1. group Id
          BG000
          value
          319
        2. group Id
          BG001
          value
          319
        3. group Id
          BG002
          value
          638
        title
        ≥ 2.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum β2 Microglobulin
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          261
        3. group Id
          BG002
          value
          522
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          270
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Bortezomib Exposure
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          158
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          318
        2. group Id
          BG001
          value
          316
        3. group Id
          BG002
          value
          634
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Lenalidomide Exposure
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice