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NCT01568866 · BASELINE

Baseline characteristics

Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients · Source last updated 2022-11-14

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
      465
    2. group Id
      BG001
      value
      464
    3. group Id
      BG002
      value
      929
    units
    Participants
groups
  1. description
    Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
    id
    BG000
    title
    Bortezomib + DEX
  2. description
    Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
    id
    BG001
    title
    Carfilzomib + DEX
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          30.0
          upper Limit
          88.0
          value
          65.0
        2. group Id
          BG001
          lower Limit
          35.0
          upper Limit
          89.0
          value
          65.0
        3. group Id
          BG002
          lower Limit
          30.0
          upper Limit
          89.0
          value
          65.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          210
        2. group Id
          BG001
          value
          223
        3. group Id
          BG002
          value
          433
        title
        < 65 years
      2. measurements
        1. group Id
          BG000
          value
          189
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          353
        title
        65 -74 years
      3. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          143
        title
        ≥ 75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          224
        3. group Id
          BG002
          value
          460
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          229
        2. group Id
          BG001
          value
          240
        3. group Id
          BG002
          value
          469
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          353
        2. group Id
          BG001
          value
          348
        3. group Id
          BG002
          value
          701
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          17
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          113
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian/Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          95
        title
        Not Reported
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Multiple
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          232
        2. group Id
          BG001
          value
          221
        3. group Id
          BG002
          value
          453
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          211
        3. group Id
          BG002
          value
          414
        title
        1 (Restrictive but ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          62
        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; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          253
        2. group Id
          BG001
          value
          252
        3. group Id
          BG002
          value
          505
        title
        Carfilzomib or bortezomib
      2. measurements
        1. group Id
          BG000
          value
          212
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          424
        title
        No prior carfilzomib or bortezomib
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Prior Proteasome Inhibitor Treatment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          229
        2. group Id
          BG001
          value
          231
        3. group Id
          BG002
          value
          460
        title
        1 line
      2. measurements
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          233
        3. group Id
          BG002
          value
          469
        title
        2 or 3 lines
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Lines of Prior Treatment
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          204
        2. group Id
          BG001
          value
          205
        3. group Id
          BG002
          value
          409
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          259
        3. group Id
          BG002
          value
          520
        title
        Stage II or III
    description
    The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group: * Stage I: β2-microglobulin (β2M) \< 3.5 mg/L, albumin \>= 3.5 g/dL * Stage II: β2M \< 3.5 mg/L and albumin \< 3.5 g/dL; or β2M 3.5 mg/L - 5.5 mg/L irrespective of the serum albumin * Stage III: β2M ≥ 5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: International Staging System (ISS) Stage
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          216
        title
        Intravenous
      2. measurements
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          356
        3. group Id
          BG002
          value
          713
        title
        Subcutaneous
    description
    The route of bortezomib administration (IV versus SC) was made in accordance with local regulatory approved route of administration. The value for this variable was selected for all participants prior to randomization to treatment group in order to balance the baseline characteristics that led to the choice of the particular route of bortezomib administration between the 2 arms.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Route of Bortezomib Administration
    unit Of Measure
    Participants
population Description
Intent-to-treat population (all randomized participants)
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      465
    2. group Id
      BG001
      value
      464
    3. group Id
      BG002
      value
      929
    units
    Participants
groups
  1. description
    Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
    id
    BG000
    title
    Bortezomib + DEX
  2. description
    Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
    id
    BG001
    title
    Carfilzomib + DEX
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          30.0
          upper Limit
          88.0
          value
          65.0
        2. group Id
          BG001
          lower Limit
          35.0
          upper Limit
          89.0
          value
          65.0
        3. group Id
          BG002
          lower Limit
          30.0
          upper Limit
          89.0
          value
          65.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          210
        2. group Id
          BG001
          value
          223
        3. group Id
          BG002
          value
          433
        title
        < 65 years
      2. measurements
        1. group Id
          BG000
          value
          189
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          353
        title
        65 -74 years
      3. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          143
        title
        ≥ 75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          224
        3. group Id
          BG002
          value
          460
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          229
        2. group Id
          BG001
          value
          240
        3. group Id
          BG002
          value
          469
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          353
        2. group Id
          BG001
          value
          348
        3. group Id
          BG002
          value
          701
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          17
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          113
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian/Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          95
        title
        Not Reported
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Multiple
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          232
        2. group Id
          BG001
          value
          221
        3. group Id
          BG002
          value
          453
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          211
        3. group Id
          BG002
          value
          414
        title
        1 (Restrictive but ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          62
        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; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          253
        2. group Id
          BG001
          value
          252
        3. group Id
          BG002
          value
          505
        title
        Carfilzomib or bortezomib
      2. measurements
        1. group Id
          BG000
          value
          212
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          424
        title
        No prior carfilzomib or bortezomib
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Prior Proteasome Inhibitor Treatment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          229
        2. group Id
          BG001
          value
          231
        3. group Id
          BG002
          value
          460
        title
        1 line
      2. measurements
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          233
        3. group Id
          BG002
          value
          469
        title
        2 or 3 lines
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Lines of Prior Treatment
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          204
        2. group Id
          BG001
          value
          205
        3. group Id
          BG002
          value
          409
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          259
        3. group Id
          BG002
          value
          520
        title
        Stage II or III
    description
    The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group: * Stage I: β2-microglobulin (β2M) \< 3.5 mg/L, albumin \>= 3.5 g/dL * Stage II: β2M \< 3.5 mg/L and albumin \< 3.5 g/dL; or β2M 3.5 mg/L - 5.5 mg/L irrespective of the serum albumin * Stage III: β2M ≥ 5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: International Staging System (ISS) Stage
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          216
        title
        Intravenous
      2. measurements
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          356
        3. group Id
          BG002
          value
          713
        title
        Subcutaneous
    description
    The route of bortezomib administration (IV versus SC) was made in accordance with local regulatory approved route of administration. The value for this variable was selected for all participants prior to randomization to treatment group in order to balance the baseline characteristics that led to the choice of the particular route of bortezomib administration between the 2 arms.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Route of Bortezomib Administration
    unit Of Measure
    Participants
population Description
Intent-to-treat population (all randomized participants)

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

Preserved source evidence · Not medical advice