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NCT03439293 · FLOW

Participant flow

A Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM) · Source last updated 2024-07-03

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

groups
  1. description
    Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
    id
    FG000
    title
    Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        22
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        28
      type
      Reason Not Specified
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Missing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        61
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        59
      comment
      Response-evaluable population was defined as participants who received at least 1 dose of ixazomib, had measurable disease either during screening or before the first dose of study drug, and had a baseline and at least 1 postbaseline disease assessment.
      type
      Response-evaluable Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        61
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with a diagnosis of relapsed and/or refractory multiple myeloma (RRMM) took part in the study to receive ixazomib + daratumumab + dexamethasone.
recruitment Details
Participants took part in the study at investigative sites in Greece, the Czech Republic, the United States, Poland, France and the Netherlands from 13 March 2018 to 26 June 2023.
Complete source fields
groups
  1. description
    Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
    id
    FG000
    title
    Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        22
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        28
      type
      Reason Not Specified
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Missing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        61
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        59
      comment
      Response-evaluable population was defined as participants who received at least 1 dose of ixazomib, had measurable disease either during screening or before the first dose of study drug, and had a baseline and at least 1 postbaseline disease assessment.
      type
      Response-evaluable Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        61
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with a diagnosis of relapsed and/or refractory multiple myeloma (RRMM) took part in the study to receive ixazomib + daratumumab + dexamethasone.
recruitment Details
Participants took part in the study at investigative sites in Greece, the Czech Republic, the United States, Poland, France and the Netherlands from 13 March 2018 to 26 June 2023.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice