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NCT01592370 · BASELINE

Baseline characteristics

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma · Source last updated 2025-10-22

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
      105
    2. group Id
      BG001
      value
      65
    3. group Id
      BG002
      value
      72
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      7
    6. group Id
      BG005
      value
      43
    7. group Id
      BG006
      value
      22
    8. group Id
      BG007
      value
      320
    units
    Participants
groups
  1. description
    3mg/kg of nivolumab
    id
    BG000
    title
    Nivolumab Monotherapy (Expansion)
  2. description
    3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
    id
    BG001
    title
    Nivolumab + Ipilimumab
  3. description
    3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
    id
    BG002
    title
    Nivolumab + Lirilumab
  4. description
    ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg)
    id
    BG003
    title
    Nivolumab + Daratumumab_Cohort A1
  5. description
    ND-PD regimen; Nivolumab + Daratumumab + Pomalidomide + Dexamethasone
    id
    BG004
    title
    Nivolumab + Daratumumab_Cohort A2
  6. description
    ND regimen: Nivolumab (240 mg cycle 1, then 480 mg) + Daratumumab (16 mg/Kg)
    id
    BG005
    title
    Nivolumab + Daratumumab_Cohort B1
  7. description
    D regimen: Daratumumab alone
    id
    BG006
    title
    Nivolumab + Daratumumab_Cohort B2
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          17
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          198
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          122
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          25
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          138
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          182
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          20
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          69
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          28
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          280
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          20
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          26
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          38
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          279
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          11
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      105
    2. group Id
      BG001
      value
      65
    3. group Id
      BG002
      value
      72
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      7
    6. group Id
      BG005
      value
      43
    7. group Id
      BG006
      value
      22
    8. group Id
      BG007
      value
      320
    units
    Participants
groups
  1. description
    3mg/kg of nivolumab
    id
    BG000
    title
    Nivolumab Monotherapy (Expansion)
  2. description
    3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
    id
    BG001
    title
    Nivolumab + Ipilimumab
  3. description
    3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
    id
    BG002
    title
    Nivolumab + Lirilumab
  4. description
    ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg)
    id
    BG003
    title
    Nivolumab + Daratumumab_Cohort A1
  5. description
    ND-PD regimen; Nivolumab + Daratumumab + Pomalidomide + Dexamethasone
    id
    BG004
    title
    Nivolumab + Daratumumab_Cohort A2
  6. description
    ND regimen: Nivolumab (240 mg cycle 1, then 480 mg) + Daratumumab (16 mg/Kg)
    id
    BG005
    title
    Nivolumab + Daratumumab_Cohort B1
  7. description
    D regimen: Daratumumab alone
    id
    BG006
    title
    Nivolumab + Daratumumab_Cohort B2
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          17
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          198
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          122
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          25
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          138
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          182
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          20
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          69
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          28
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          280
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          20
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          26
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          38
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          279
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          11
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice