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NCT03412565 · BASELINE

Baseline characteristics

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens · Source last updated 2025-04-29

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
      67
    2. group Id
      BG001
      value
      67
    3. group Id
      BG002
      value
      65
    4. group Id
      BG003
      value
      66
    5. group Id
      BG004
      value
      265
    units
    Participants
groups
  1. description
    Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m\^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
    id
    BG000
    title
    Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)
  2. description
    Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; bortezomib 1.3 mg/m\^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m\^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m\^2 orally on Days 1 to 4 of cycles 1 to 9.
    id
    BG001
    title
    D + Bortezomib + Melphalan + Prednisone (D-VMP)
  3. description
    Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.
    id
    BG002
    title
    Daratumumab + Lenalidomide + Dexamethasone (D-Rd)
  4. description
    Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m\^2 IV on Day 1 of Cycle 1 only, then 70 mg/m\^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.
    id
    BG003
    title
    Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.47
          value
          57.3
        2. group Id
          BG001
          spread
          4.54
          value
          74.9
        3. group Id
          BG002
          spread
          9.58
          value
          66.8
        4. group Id
          BG003
          spread
          9.77
          value
          61
        5. group Id
          BG004
          spread
          10.87
          value
          65
    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
          19
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          107
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          34
        5. group Id
          BG004
          value
          158
        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
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          161
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          88
        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
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        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
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          48
        5. group Id
          BG004
          value
          177
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          73
        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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
      title
      BRAZIL
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          23
      title
      CZECH REPUBLIC
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          79
      title
      FRANCE
    4. 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
          19
        5. group Id
          BG004
          value
          19
      title
      GERMANY
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          21
      title
      ISRAEL
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
      title
      JAPAN
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          25
        5. group Id
          BG004
          value
          55
      title
      SPAIN
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          29
      title
      UNITED KINGDOM
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          30
      title
      UNITED STATES
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      67
    2. group Id
      BG001
      value
      67
    3. group Id
      BG002
      value
      65
    4. group Id
      BG003
      value
      66
    5. group Id
      BG004
      value
      265
    units
    Participants
groups
  1. description
    Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m\^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
    id
    BG000
    title
    Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)
  2. description
    Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; bortezomib 1.3 mg/m\^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m\^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m\^2 orally on Days 1 to 4 of cycles 1 to 9.
    id
    BG001
    title
    D + Bortezomib + Melphalan + Prednisone (D-VMP)
  3. description
    Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.
    id
    BG002
    title
    Daratumumab + Lenalidomide + Dexamethasone (D-Rd)
  4. description
    Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m\^2 IV on Day 1 of Cycle 1 only, then 70 mg/m\^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.
    id
    BG003
    title
    Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.47
          value
          57.3
        2. group Id
          BG001
          spread
          4.54
          value
          74.9
        3. group Id
          BG002
          spread
          9.58
          value
          66.8
        4. group Id
          BG003
          spread
          9.77
          value
          61
        5. group Id
          BG004
          spread
          10.87
          value
          65
    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
          19
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          107
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          34
        5. group Id
          BG004
          value
          158
        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
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          161
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          88
        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
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        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
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          48
        5. group Id
          BG004
          value
          177
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          73
        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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
      title
      BRAZIL
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          23
      title
      CZECH REPUBLIC
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          79
      title
      FRANCE
    4. 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
          19
        5. group Id
          BG004
          value
          19
      title
      GERMANY
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          21
      title
      ISRAEL
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
      title
      JAPAN
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          25
        5. group Id
          BG004
          value
          55
      title
      SPAIN
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          29
      title
      UNITED KINGDOM
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          30
      title
      UNITED STATES
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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