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NCT00603447 · BASELINE

Baseline characteristics

Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma · Source last updated 2017-05-30

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
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      8
    7. group Id
      BG006
      value
      44
    8. group Id
      BG007
      value
      84
    units
    Participants
groups
  1. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG000
    title
    1: CFZ 15 mg/m² + LEN 10 mg
  2. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG001
    title
    2: CFZ 15 mg/m² + LEN 15 mg
  3. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG002
    title
    3: CFZ 15 mg/m² + LEN 20 mg
  4. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG003
    title
    4: CFZ 20 mg/m² + LEN 20 mg
  5. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG004
    title
    5: CFZ 20 mg/m² + LEN 25 mg
  6. description
    Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG005
    title
    6: CFZ 20/27 mg/m² + LEN 25 mg
  7. description
    In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG006
    title
    7: CFZ 20/27 mg/m² + LEN 25 mg
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.65
          value
          64.7
        2. group Id
          BG001
          spread
          12.11
          value
          64.2
        3. group Id
          BG002
          spread
          7.74
          value
          55.4
        4. group Id
          BG003
          spread
          6.68
          value
          61.7
        5. group Id
          BG004
          spread
          9.31
          value
          57.7
        6. group Id
          BG005
          spread
          7.85
          value
          65.4
        7. group Id
          BG006
          spread
          10.75
          value
          62.4
        8. group Id
          BG007
          spread
          9.86
          value
          61.9
    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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          18
        8. group Id
          BG007
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          48
        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
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          9
      title
      African American
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          3
      title
      Asian/Pacific Islander
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          34
        8. group Id
          BG007
          value
          64
      title
      Caucasian
    4. 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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          7
      title
      Hispanic
    5. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          23
        8. group Id
          BG007
          value
          33
      title
      0 (Fully active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          46
      title
      1 (Restrictive but ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          5
      title
      2 (Ambulatory but unable to work)
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active; 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, no self-care, confined to bed or chair.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          4
          value
          3.3
        2. group Id
          BG001
          lower Limit
          2
          upper Limit
          5
          value
          2.4
        3. group Id
          BG002
          lower Limit
          2
          upper Limit
          15
          value
          3.9
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          9
          value
          2.8
        5. group Id
          BG004
          lower Limit
          1
          upper Limit
          22
          value
          3.5
        6. group Id
          BG005
          lower Limit
          1
          upper Limit
          12
          value
          4.3
        7. group Id
          BG006
          lower Limit
          0
          upper Limit
          16
          value
          2.8
        8. group Id
          BG007
          lower Limit
          0
          upper Limit
          22
          value
          3.1
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time Since Diagnosis
    unit Of Measure
    years
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      8
    7. group Id
      BG006
      value
      44
    8. group Id
      BG007
      value
      84
    units
    Participants
groups
  1. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG000
    title
    1: CFZ 15 mg/m² + LEN 10 mg
  2. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG001
    title
    2: CFZ 15 mg/m² + LEN 15 mg
  3. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG002
    title
    3: CFZ 15 mg/m² + LEN 20 mg
  4. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG003
    title
    4: CFZ 20 mg/m² + LEN 20 mg
  5. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG004
    title
    5: CFZ 20 mg/m² + LEN 25 mg
  6. description
    Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG005
    title
    6: CFZ 20/27 mg/m² + LEN 25 mg
  7. description
    In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    BG006
    title
    7: CFZ 20/27 mg/m² + LEN 25 mg
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.65
          value
          64.7
        2. group Id
          BG001
          spread
          12.11
          value
          64.2
        3. group Id
          BG002
          spread
          7.74
          value
          55.4
        4. group Id
          BG003
          spread
          6.68
          value
          61.7
        5. group Id
          BG004
          spread
          9.31
          value
          57.7
        6. group Id
          BG005
          spread
          7.85
          value
          65.4
        7. group Id
          BG006
          spread
          10.75
          value
          62.4
        8. group Id
          BG007
          spread
          9.86
          value
          61.9
    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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          18
        8. group Id
          BG007
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          48
        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
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          9
      title
      African American
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          3
      title
      Asian/Pacific Islander
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          34
        8. group Id
          BG007
          value
          64
      title
      Caucasian
    4. 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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          7
      title
      Hispanic
    5. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          23
        8. group Id
          BG007
          value
          33
      title
      0 (Fully active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          46
      title
      1 (Restrictive but ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          5
      title
      2 (Ambulatory but unable to work)
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active; 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, no self-care, confined to bed or chair.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          4
          value
          3.3
        2. group Id
          BG001
          lower Limit
          2
          upper Limit
          5
          value
          2.4
        3. group Id
          BG002
          lower Limit
          2
          upper Limit
          15
          value
          3.9
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          9
          value
          2.8
        5. group Id
          BG004
          lower Limit
          1
          upper Limit
          22
          value
          3.5
        6. group Id
          BG005
          lower Limit
          1
          upper Limit
          12
          value
          4.3
        7. group Id
          BG006
          lower Limit
          0
          upper Limit
          16
          value
          2.8
        8. group Id
          BG007
          lower Limit
          0
          upper Limit
          22
          value
          3.1
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time Since Diagnosis
    unit Of Measure
    years

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Preserved source evidence · Not medical advice