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NCT02046070 · BASELINE

Baseline characteristics

Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma · Source last updated 2019-07-17

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
      36
    2. group Id
      BG001
      value
      34
    3. group Id
      BG002
      value
      78
    4. group Id
      BG003
      value
      148
    units
    Participants
groups
  1. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
    id
    BG000
    title
    Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)
  2. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
    id
    BG001
    title
    Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)
  3. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.
    id
    BG002
    title
    Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.48
          value
          73.4
        2. group Id
          BG001
          spread
          5.80
          value
          74.1
        3. group Id
          BG002
          spread
          9.85
          value
          63.5
        4. group Id
          BG003
          spread
          9.59
          value
          68.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
    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
          21
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          74
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          74
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
    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
          0
        4. group Id
          BG003
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          75
        4. group Id
          BG003
          value
          143
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          74
        4. group Id
          BG003
          value
          143
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
      title
      Other
    3. 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
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
      title
      Asian
    4. 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
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
      title
      Black or African American
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.35
          value
          163.5
        2. group Id
          BG001
          spread
          12.47
          value
          163.5
        3. group Id
          BG002
          spread
          10.47
          value
          165.9
        4. group Id
          BG003
          spread
          11.16
          value
          164.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          77
        4. group Id
          BG003
          value
          147
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number Analyzed is the number of participants with data available for analysis.
    title
    Height
    unit Of Measure
    centimeters (cm)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.8
          value
          73.6
        2. group Id
          BG001
          spread
          17.54
          value
          73.0
        3. group Id
          BG002
          spread
          16.80
          value
          78.1
        4. group Id
          BG003
          spread
          15.99
          value
          75.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilograms (kg)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.17
          value
          1.8
        2. group Id
          BG001
          spread
          0.26
          value
          1.8
        3. group Id
          BG002
          spread
          0.23
          value
          1.9
        4. group Id
          BG003
          spread
          0.23
          value
          1.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
    description
    BSA = square root (height(cm) x weight (kg) / 3600.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    meters squared (m^2)
population Description
Safety population was defined as all participants who received at least 1 dose of any study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      36
    2. group Id
      BG001
      value
      34
    3. group Id
      BG002
      value
      78
    4. group Id
      BG003
      value
      148
    units
    Participants
groups
  1. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
    id
    BG000
    title
    Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)
  2. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
    id
    BG001
    title
    Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)
  3. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.
    id
    BG002
    title
    Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.48
          value
          73.4
        2. group Id
          BG001
          spread
          5.80
          value
          74.1
        3. group Id
          BG002
          spread
          9.85
          value
          63.5
        4. group Id
          BG003
          spread
          9.59
          value
          68.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
    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
          21
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          74
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          74
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
    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
          0
        4. group Id
          BG003
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          75
        4. group Id
          BG003
          value
          143
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          74
        4. group Id
          BG003
          value
          143
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
      title
      Other
    3. 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
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
      title
      Asian
    4. 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
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
      title
      Black or African American
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.35
          value
          163.5
        2. group Id
          BG001
          spread
          12.47
          value
          163.5
        3. group Id
          BG002
          spread
          10.47
          value
          165.9
        4. group Id
          BG003
          spread
          11.16
          value
          164.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          77
        4. group Id
          BG003
          value
          147
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number Analyzed is the number of participants with data available for analysis.
    title
    Height
    unit Of Measure
    centimeters (cm)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.8
          value
          73.6
        2. group Id
          BG001
          spread
          17.54
          value
          73.0
        3. group Id
          BG002
          spread
          16.80
          value
          78.1
        4. group Id
          BG003
          spread
          15.99
          value
          75.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilograms (kg)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.17
          value
          1.8
        2. group Id
          BG001
          spread
          0.26
          value
          1.8
        3. group Id
          BG002
          spread
          0.23
          value
          1.9
        4. group Id
          BG003
          spread
          0.23
          value
          1.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          148
        units
        Participants
    description
    BSA = square root (height(cm) x weight (kg) / 3600.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    meters squared (m^2)
population Description
Safety population was defined as all participants who received at least 1 dose of any study drug.

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