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NCT00530816 · BASELINE

Baseline characteristics

Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma · Source last updated 2017-05-02

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
      35
    2. group Id
      BG001
      value
      59
    3. group Id
      BG002
      value
      70
    4. group Id
      BG003
      value
      164
    units
    Participants
groups
  1. description
    Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
    id
    BG000
    title
    Part 1: Carfilzomib 20 mg/m²
  2. description
    Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
    id
    BG001
    title
    Part 2: Carfilzomib 20 mg/m²
  3. description
    Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
    id
    BG002
    title
    Part 2: Carfilzomib 20/27 mg/m²
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. 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
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          81
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          83
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          94
        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
          15
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          67
      title
      0 (Fully Active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          87
      title
      1 (Restrictive but ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          9
      title
      2 (Ambulatory but unable to work)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Missing
    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; 5 = Death.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          20
      title
      SPEP and UPEP
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          108
      title
      SPEP
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          22
      title
      UPEP
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          11
      title
      SFLC Only
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      IgA, by Immunoglobulin Assay Only
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Missing
    description
    Measurable disease categories defined as: SPEP: Serum M-protein ≥ 1 g/dL by serum protein electrophoresis (SPEP); UPEP: Urine M-protein ≥ 200 mg/24 hour by urine protein electrophoresis (UPEP); SPEP and UPEP: M-protein levels ≥ 1 g/dL in serum and ≥ 200 mg/24 hours; SFLC Only: Detectable using serum free light chain (SFLC) assay only (participants enrolled prior to Amendment 2); IgA only: For patients with immunoglobulin A (IgA) myeloma for whom SPEP is considered unreliable, quantitative immunoglobulin (e.g. nephelometry or turbidometry) was performed.
    param Type
    NUMBER
    title
    Measurable Disease Category
    unit Of Measure
    participants
population Description
Safety Population: All patients enrolled on study and who received at least 1 dose of carfilzomib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      35
    2. group Id
      BG001
      value
      59
    3. group Id
      BG002
      value
      70
    4. group Id
      BG003
      value
      164
    units
    Participants
groups
  1. description
    Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
    id
    BG000
    title
    Part 1: Carfilzomib 20 mg/m²
  2. description
    Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
    id
    BG001
    title
    Part 2: Carfilzomib 20 mg/m²
  3. description
    Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
    id
    BG002
    title
    Part 2: Carfilzomib 20/27 mg/m²
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. 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
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          81
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          83
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          94
        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
          15
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          67
      title
      0 (Fully Active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          87
      title
      1 (Restrictive but ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          9
      title
      2 (Ambulatory but unable to work)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Missing
    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; 5 = Death.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          20
      title
      SPEP and UPEP
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          108
      title
      SPEP
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          22
      title
      UPEP
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          11
      title
      SFLC Only
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      IgA, by Immunoglobulin Assay Only
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Missing
    description
    Measurable disease categories defined as: SPEP: Serum M-protein ≥ 1 g/dL by serum protein electrophoresis (SPEP); UPEP: Urine M-protein ≥ 200 mg/24 hour by urine protein electrophoresis (UPEP); SPEP and UPEP: M-protein levels ≥ 1 g/dL in serum and ≥ 200 mg/24 hours; SFLC Only: Detectable using serum free light chain (SFLC) assay only (participants enrolled prior to Amendment 2); IgA only: For patients with immunoglobulin A (IgA) myeloma for whom SPEP is considered unreliable, quantitative immunoglobulin (e.g. nephelometry or turbidometry) was performed.
    param Type
    NUMBER
    title
    Measurable Disease Category
    unit Of Measure
    participants
population Description
Safety Population: All patients enrolled on study and who received at least 1 dose of carfilzomib.

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Preserved source evidence · Not medical advice