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NCT02076009 · FLOW

Participant flow

A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma · Source last updated 2025-05-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).
    id
    FG000
    title
    Lenalidomide, Low-dose Dexamethasone (Rd)
  2. description
    Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).
    id
    FG001
    title
    Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        172
      2. group Id
        FG001
        num Subjects
        153
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        12
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Progressive Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        90
      2. group Id
        FG001
        num Subjects
        118
      type
      End of data collection
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        283
      2. group Id
        FG001
        num Subjects
        286
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        281
      2. group Id
        FG001
        num Subjects
        283
      type
      Treated (Safety Population)
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        283
      2. group Id
        FG001
        num Subjects
        286
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).
    id
    FG000
    title
    Lenalidomide, Low-dose Dexamethasone (Rd)
  2. description
    Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).
    id
    FG001
    title
    Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        172
      2. group Id
        FG001
        num Subjects
        153
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        12
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Progressive Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        90
      2. group Id
        FG001
        num Subjects
        118
      type
      End of data collection
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        283
      2. group Id
        FG001
        num Subjects
        286
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        281
      2. group Id
        FG001
        num Subjects
        283
      type
      Treated (Safety Population)
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        283
      2. group Id
        FG001
        num Subjects
        286
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice