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NCT02579863 · BASELINE

Baseline characteristics

Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185) · Source last updated 2021-07-20

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
      156
    2. group Id
      BG001
      value
      154
    3. group Id
      BG002
      value
      310
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
    id
    BG000
    title
    Pembrolizumab + Lenalidomide + Dexamethasone
  2. description
    Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
    id
    BG001
    title
    Lenolidomide + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.0
          value
          74.4
        2. group Id
          BG001
          spread
          5.9
          value
          74.3
        3. group Id
          BG002
          spread
          6.0
          value
          74.3
    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
          85
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          166
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          144
        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
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          143
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          279
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          54
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          236
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          92
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          136
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          80
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Missing
    description
    The International Staging System (ISS) defines the factors that influence patient survival. The system has 3 stages based on the measurement of serum albumin and the levels of serum β2-microglobulin (β2-M). Stage I: β2-M \<3.5 mg/L with a serum albumin of 3.5 g/dL or more; Stage II: Either of these 2 criteria: β2-M between 3.5 mg/L and 5.5 mg/dL Albumin \<3.5 g/dL; Stage III: β2-M \>5.5 mg/L.
    param Type
    NUMBER
    title
    International Stage (I, II, III).
    unit Of Measure
    Participants
population Description
The analysis population included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      156
    2. group Id
      BG001
      value
      154
    3. group Id
      BG002
      value
      310
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
    id
    BG000
    title
    Pembrolizumab + Lenalidomide + Dexamethasone
  2. description
    Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
    id
    BG001
    title
    Lenolidomide + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.0
          value
          74.4
        2. group Id
          BG001
          spread
          5.9
          value
          74.3
        3. group Id
          BG002
          spread
          6.0
          value
          74.3
    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
          85
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          166
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          144
        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
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          143
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          279
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          54
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          236
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          92
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          136
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          80
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Missing
    description
    The International Staging System (ISS) defines the factors that influence patient survival. The system has 3 stages based on the measurement of serum albumin and the levels of serum β2-microglobulin (β2-M). Stage I: β2-M \<3.5 mg/L with a serum albumin of 3.5 g/dL or more; Stage II: Either of these 2 criteria: β2-M between 3.5 mg/L and 5.5 mg/dL Albumin \<3.5 g/dL; Stage III: β2-M \>5.5 mg/L.
    param Type
    NUMBER
    title
    International Stage (I, II, III).
    unit Of Measure
    Participants
population Description
The analysis population included all randomized participants.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice