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NCT01818752 · BASELINE

Baseline characteristics

Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma · Source last updated 2019-08-26

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
      477
    2. group Id
      BG001
      value
      478
    3. group Id
      BG002
      value
      955
    units
    Participants
groups
  1. description
    Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
    id
    BG000
    title
    Bortezomib, Melphalan, Prednisone
  2. description
    Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
    id
    BG001
    title
    Carfilzomib, Melphalan, Prednisone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.5
          value
          71.5
        2. group Id
          BG001
          spread
          5.7
          value
          72.0
        3. group Id
          BG002
          spread
          6.1
          value
          71.7
    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
          238
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          473
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          482
        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
          18
        3. group Id
          BG002
          value
          33
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          443
        2. group Id
          BG001
          value
          427
        3. group Id
          BG002
          value
          870
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          52
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          121
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          244
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          339
        2. group Id
          BG001
          value
          329
        3. group Id
          BG002
          value
          668
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Multiple
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          31
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          194
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          378
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          761
      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
    NUMBER
    title
    Stratification Factor: International Staging System (ISS) Stage
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          246
      title
      Intravenous
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          354
        2. group Id
          BG001
          value
          355
        3. group Id
          BG002
          value
          709
      title
      Subcutaneous
    description
    The route of bortezomib administration (IV versus SC) was made per investigator's choice, dose modification, or regulatory approval. The investigator selected the route for all participants prior to randomization to treatment group in order to minimize any evaluation bias because of imbalances in potential prognostic factors that might have impacted the investigator's choice of a particular route.
    param Type
    NUMBER
    title
    Stratification Factor: Route of Bortezomib Administration
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          140
        3. group Id
          BG002
          value
          281
      title
      Asia Pacific
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
      title
      North America
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          317
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          637
      title
      Europe
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          17
      title
      Other
    param Type
    NUMBER
    title
    Stratification Factor: Region of Enrollment
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          327
        3. group Id
          BG002
          value
          656
      title
      < 75 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          299
      title
      ≥ 75 years
    param Type
    NUMBER
    title
    Stratification Factor: Age
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          254
      title
      0 (Fully active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          260
        3. group Id
          BG002
          value
          510
      title
      1 (Restrictive but ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          190
      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
          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 = Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      477
    2. group Id
      BG001
      value
      478
    3. group Id
      BG002
      value
      955
    units
    Participants
groups
  1. description
    Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
    id
    BG000
    title
    Bortezomib, Melphalan, Prednisone
  2. description
    Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
    id
    BG001
    title
    Carfilzomib, Melphalan, Prednisone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.5
          value
          71.5
        2. group Id
          BG001
          spread
          5.7
          value
          72.0
        3. group Id
          BG002
          spread
          6.1
          value
          71.7
    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
          238
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          473
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          482
        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
          18
        3. group Id
          BG002
          value
          33
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          443
        2. group Id
          BG001
          value
          427
        3. group Id
          BG002
          value
          870
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          52
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          121
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          244
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          339
        2. group Id
          BG001
          value
          329
        3. group Id
          BG002
          value
          668
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Multiple
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          31
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          194
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          378
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          761
      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
    NUMBER
    title
    Stratification Factor: International Staging System (ISS) Stage
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          246
      title
      Intravenous
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          354
        2. group Id
          BG001
          value
          355
        3. group Id
          BG002
          value
          709
      title
      Subcutaneous
    description
    The route of bortezomib administration (IV versus SC) was made per investigator's choice, dose modification, or regulatory approval. The investigator selected the route for all participants prior to randomization to treatment group in order to minimize any evaluation bias because of imbalances in potential prognostic factors that might have impacted the investigator's choice of a particular route.
    param Type
    NUMBER
    title
    Stratification Factor: Route of Bortezomib Administration
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          140
        3. group Id
          BG002
          value
          281
      title
      Asia Pacific
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
      title
      North America
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          317
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          637
      title
      Europe
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          17
      title
      Other
    param Type
    NUMBER
    title
    Stratification Factor: Region of Enrollment
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          327
        3. group Id
          BG002
          value
          656
      title
      < 75 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          299
      title
      ≥ 75 years
    param Type
    NUMBER
    title
    Stratification Factor: Age
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          254
      title
      0 (Fully active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          260
        3. group Id
          BG002
          value
          510
      title
      1 (Restrictive but ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          190
      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
          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 = Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice