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NCT02874742 · BASELINE

Baseline characteristics

Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma · Source last updated 2025-02-04

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
      103
    2. group Id
      BG001
      value
      104
    3. group Id
      BG002
      value
      16
    4. group Id
      BG003
      value
      223
    units
    Participants
groups
  1. description
    Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy \[HDT\] and autologous stem cell transplantation \[ASCT\]; 6-week consolidation phase)- participants received lenalidomide 25 milligrams (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 mg per meter square (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week \[until disease progression/up to maximum of 2 years\])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
    id
    BG000
    title
    Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd)
  2. description
    Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week \[until disease progression/up to maximum of 2 years\])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator.
    id
    BG001
    title
    Randomized: Daratumumab+RVd (D-RVd)
  3. description
    Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week \[until disease progression/up to maximum of 2 years\])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
    id
    BG002
    title
    Safety Run-in: D-RVd
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.27
          value
          59
        2. group Id
          BG001
          spread
          9.79
          value
          57.2
        3. group Id
          BG002
          spread
          5.96
          value
          59.8
        4. group Id
          BG003
          spread
          8.49
          value
          58.2
    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
          43
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          97
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          126
        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
          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. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          36
      title
      Black or African American
    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
          0
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          172
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      More than one race
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
      title
      Unknown or Not Reported
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          223
      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
      103
    2. group Id
      BG001
      value
      104
    3. group Id
      BG002
      value
      16
    4. group Id
      BG003
      value
      223
    units
    Participants
groups
  1. description
    Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy \[HDT\] and autologous stem cell transplantation \[ASCT\]; 6-week consolidation phase)- participants received lenalidomide 25 milligrams (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 mg per meter square (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week \[until disease progression/up to maximum of 2 years\])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
    id
    BG000
    title
    Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd)
  2. description
    Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week \[until disease progression/up to maximum of 2 years\])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator.
    id
    BG001
    title
    Randomized: Daratumumab+RVd (D-RVd)
  3. description
    Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week \[until disease progression/up to maximum of 2 years\])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
    id
    BG002
    title
    Safety Run-in: D-RVd
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.27
          value
          59
        2. group Id
          BG001
          spread
          9.79
          value
          57.2
        3. group Id
          BG002
          spread
          5.96
          value
          59.8
        4. group Id
          BG003
          spread
          8.49
          value
          58.2
    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
          43
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          97
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          126
        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
          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. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          36
      title
      Black or African American
    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
          0
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          172
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      More than one race
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
      title
      Unknown or Not Reported
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          223
      title
      UNITED STATES
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice