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NCT03652064 · BASELINE

Baseline characteristics

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy · Source last updated 2026-06-02

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
      198
    2. group Id
      BG001
      value
      197
    3. group Id
      BG002
      value
      395
    units
    Participants
groups
  1. description
    Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
    id
    BG000
    title
    Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
  2. description
    Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
    id
    BG001
    title
    Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          31
          upper Limit
          80
          value
          70.0
        2. group Id
          BG001
          lower Limit
          42
          upper Limit
          79
          value
          70.0
        3. group Id
          BG002
          lower Limit
          31
          upper Limit
          80
          value
          70
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          197
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          198
        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
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          154
        3. group Id
          BG002
          value
          301
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          28
        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
          156
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          318
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
      title
      Asian
    4. categories
      1. 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
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          29
      title
      Not reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      198
    2. group Id
      BG001
      value
      197
    3. group Id
      BG002
      value
      395
    units
    Participants
groups
  1. description
    Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
    id
    BG000
    title
    Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
  2. description
    Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
    id
    BG001
    title
    Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          31
          upper Limit
          80
          value
          70.0
        2. group Id
          BG001
          lower Limit
          42
          upper Limit
          79
          value
          70.0
        3. group Id
          BG002
          lower Limit
          31
          upper Limit
          80
          value
          70
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          197
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          198
        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
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          154
        3. group Id
          BG002
          value
          301
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          28
        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
          156
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          318
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
      title
      Asian
    4. categories
      1. 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
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          29
      title
      Not reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice