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NCT02136134 · FLOW

Participant flow

Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-08-29

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

groups
  1. description
    Participants received bortezomib 1.3 milligrams per square meter (mg/m\^2) subcutaneous (SC) injection on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 milligrams (mg) orally (PO) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Participants who met sponsor confirmed disease progression eligibility criteria received daratumumab monotherapy as a subsequent antimyeloma therapy as follow: daratumumab 16 milligrams per kilogram (mg/kg) intravenous (IV) infusion or daratumumab SC injection (1800 mg fixed dose) weekly for the first 2 cycles, every 2 weeks from Cycle 3 to 6, and then every 4 weeks thereafter.
    id
    FG000
    title
    Bortezomib + Dexamethasone (Vd)
  2. description
    Participants received daratumumab 16 mg/kg IV infusion weekly or daratumumab SC injection (1800 mg fixed dose) for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib 1.3 mg/m\^2 SC injection administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
    id
    FG001
    title
    Daratumumab + Bortezomib and Dexamethasone (DVd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        170
      2. group Id
        FG001
        num Subjects
        148
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        90
      type
      Uspecified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        247
      2. group Id
        FG001
        num Subjects
        251
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        87
      2. group Id
        FG001
        num Subjects
        0
      type
      Daratumumab Monotherapy
    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
        247
      2. group Id
        FG001
        num Subjects
        251
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Participants received bortezomib 1.3 milligrams per square meter (mg/m\^2) subcutaneous (SC) injection on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 milligrams (mg) orally (PO) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Participants who met sponsor confirmed disease progression eligibility criteria received daratumumab monotherapy as a subsequent antimyeloma therapy as follow: daratumumab 16 milligrams per kilogram (mg/kg) intravenous (IV) infusion or daratumumab SC injection (1800 mg fixed dose) weekly for the first 2 cycles, every 2 weeks from Cycle 3 to 6, and then every 4 weeks thereafter.
    id
    FG000
    title
    Bortezomib + Dexamethasone (Vd)
  2. description
    Participants received daratumumab 16 mg/kg IV infusion weekly or daratumumab SC injection (1800 mg fixed dose) for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib 1.3 mg/m\^2 SC injection administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
    id
    FG001
    title
    Daratumumab + Bortezomib and Dexamethasone (DVd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        170
      2. group Id
        FG001
        num Subjects
        148
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        90
      type
      Uspecified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        247
      2. group Id
        FG001
        num Subjects
        251
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        87
      2. group Id
        FG001
        num Subjects
        0
      type
      Daratumumab Monotherapy
    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
        247
      2. group Id
        FG001
        num Subjects
        251
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice