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NCT02312258 · FLOW

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A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT) · Source last updated 2023-09-21

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

groups
  1. description
    Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
    id
    FG000
    title
    Placebo
  2. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
    id
    FG001
    title
    Ixazomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        76
      type
      Withdrawal by Patient
    3. reasons
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        159
      type
      Reason not Specified
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Missing
    5. reasons
      1. group Id
        FG000
        num Subjects
        115
      2. group Id
        FG001
        num Subjects
        181
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        281
      2. group Id
        FG001
        num Subjects
        425
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        276
      2. group Id
        FG001
        num Subjects
        426
      comment
      The safety population was defined as all participants who received at least 1 dose of ixazomib or placebo. Three placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population.
      type
      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
        281
      2. group Id
        FG001
        num Subjects
        425
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with newly diagnosed multiple myeloma not treated with stem cell transplantation (SCT) were enrolled and randomized in a 3:2 ratio to receive ixazomib or placebo respectively.
recruitment Details
Participants took part in the study from 09 April 2015 to 26 August 2022.
Complete source fields
groups
  1. description
    Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
    id
    FG000
    title
    Placebo
  2. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
    id
    FG001
    title
    Ixazomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        76
      type
      Withdrawal by Patient
    3. reasons
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        159
      type
      Reason not Specified
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Missing
    5. reasons
      1. group Id
        FG000
        num Subjects
        115
      2. group Id
        FG001
        num Subjects
        181
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        281
      2. group Id
        FG001
        num Subjects
        425
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        276
      2. group Id
        FG001
        num Subjects
        426
      comment
      The safety population was defined as all participants who received at least 1 dose of ixazomib or placebo. Three placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population.
      type
      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
        281
      2. group Id
        FG001
        num Subjects
        425
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with newly diagnosed multiple myeloma not treated with stem cell transplantation (SCT) were enrolled and randomized in a 3:2 ratio to receive ixazomib or placebo respectively.
recruitment Details
Participants took part in the study from 09 April 2015 to 26 August 2022.

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Preserved source evidence · Not medical advice