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NCT01441973 · BASELINE

Baseline characteristics

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma · Source last updated 2018-01-23

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
      15
    2. group Id
      BG001
      value
      16
    3. group Id
      BG002
      value
      31
    units
    Participants
groups
  1. description
    Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
    id
    BG000
    title
    Elotuzumab, 20 mg/kg
  2. description
    Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
    id
    BG001
    title
    Elotuzumab, 10 mg/kg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.75
          value
          59.0
        2. group Id
          BG001
          spread
          9.37
          value
          59.3
        3. group Id
          BG002
          spread
          9.40
          value
          59.2
    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
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          23
      title
      Younger than 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
      title
      65 years and older to younger than 75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      75 years and older
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          30
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Black or African American
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.19
          value
          29.5
        2. group Id
          BG001
          spread
          11.46
          value
          21.9
        3. group Id
          BG002
          spread
          13.72
          value
          25.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum monoclonal (M) protein
    unit Of Measure
    g/L
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.6199
          value
          0.208
        2. group Id
          BG001
          spread
          0.2131
          value
          0.094
        3. group Id
          BG002
          spread
          0.4532
          value
          0.149
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Urine M protein
    unit Of Measure
    g/day
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          37.572
          value
          31.75
        2. group Id
          BG001
          spread
          35.103
          value
          36.81
        3. group Id
          BG002
          spread
          35.798
          value
          34.37
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time from diagnosis to enrollment
    unit Of Measure
    Months
population Description
All participants who received at least 1 dose of study medication
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      15
    2. group Id
      BG001
      value
      16
    3. group Id
      BG002
      value
      31
    units
    Participants
groups
  1. description
    Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
    id
    BG000
    title
    Elotuzumab, 20 mg/kg
  2. description
    Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
    id
    BG001
    title
    Elotuzumab, 10 mg/kg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.75
          value
          59.0
        2. group Id
          BG001
          spread
          9.37
          value
          59.3
        3. group Id
          BG002
          spread
          9.40
          value
          59.2
    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
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          23
      title
      Younger than 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
      title
      65 years and older to younger than 75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      75 years and older
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          30
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Black or African American
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.19
          value
          29.5
        2. group Id
          BG001
          spread
          11.46
          value
          21.9
        3. group Id
          BG002
          spread
          13.72
          value
          25.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum monoclonal (M) protein
    unit Of Measure
    g/L
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.6199
          value
          0.208
        2. group Id
          BG001
          spread
          0.2131
          value
          0.094
        3. group Id
          BG002
          spread
          0.4532
          value
          0.149
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Urine M protein
    unit Of Measure
    g/day
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          37.572
          value
          31.75
        2. group Id
          BG001
          spread
          35.103
          value
          36.81
        3. group Id
          BG002
          spread
          35.798
          value
          34.37
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time from diagnosis to enrollment
    unit Of Measure
    Months
population Description
All participants who received at least 1 dose of study medication

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Preserved source evidence · Not medical advice