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NCT02726581 · BASELINE

Baseline characteristics

An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma · Source last updated 2023-03-27

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
      75
    2. group Id
      BG001
      value
      71
    3. group Id
      BG002
      value
      24
    4. group Id
      BG003
      value
      170
    units
    Participants
groups
  1. description
    Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    BG000
    title
    Arm A: N-Pd
  2. description
    Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    BG001
    title
    Arm B: Pd
  3. description
    Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Elotuzumab: * Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle. * Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle. * Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle. Pomalidomide: 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Days 1, 8, 15, and 22 of each cycle. * Participants \</= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks. * Participants \> 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.
    id
    BG002
    title
    Arm C: NE-Pd
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          65.9
        2. group Id
          BG001
          spread
          8.7
          value
          65.5
        3. group Id
          BG002
          spread
          11.5
          value
          66.2
        4. group Id
          BG003
          spread
          9.4
          value
          65.8
    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
          24
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          57
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          113
        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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          96
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          68
        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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          155
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      75
    2. group Id
      BG001
      value
      71
    3. group Id
      BG002
      value
      24
    4. group Id
      BG003
      value
      170
    units
    Participants
groups
  1. description
    Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    BG000
    title
    Arm A: N-Pd
  2. description
    Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    BG001
    title
    Arm B: Pd
  3. description
    Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Elotuzumab: * Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle. * Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle. * Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle. Pomalidomide: 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Days 1, 8, 15, and 22 of each cycle. * Participants \</= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks. * Participants \> 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.
    id
    BG002
    title
    Arm C: NE-Pd
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          65.9
        2. group Id
          BG001
          spread
          8.7
          value
          65.5
        3. group Id
          BG002
          spread
          11.5
          value
          66.2
        4. group Id
          BG003
          spread
          9.4
          value
          65.8
    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
          24
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          57
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          113
        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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          96
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          68
        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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          155
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice