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NCT02272803 · BASELINE

Baseline characteristics

Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan · Source last updated 2022-06-22

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
      40
    2. group Id
      BG001
      value
      42
    3. group Id
      BG002
      value
      82
    units
    Participants
groups
  1. description
    Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1
    id
    BG000
    title
    Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
  2. description
    Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
    id
    BG001
    title
    Arm B: Lenalidomide + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.91
          value
          72.6
        2. group Id
          BG001
          spread
          6.32
          value
          74.0
        3. group Id
          BG002
          spread
          5.69
          value
          73.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    All treated participants
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          43
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          39
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. 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
          40
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          82
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. 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
    population Description
    All treated participants
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All treated particpants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      40
    2. group Id
      BG001
      value
      42
    3. group Id
      BG002
      value
      82
    units
    Participants
groups
  1. description
    Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1
    id
    BG000
    title
    Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
  2. description
    Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
    id
    BG001
    title
    Arm B: Lenalidomide + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.91
          value
          72.6
        2. group Id
          BG001
          spread
          6.32
          value
          74.0
        3. group Id
          BG002
          spread
          5.69
          value
          73.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    All treated participants
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          43
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          39
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. 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
          40
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          82
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. 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
    population Description
    All treated participants
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All treated particpants

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

Preserved source evidence · Not medical advice