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NCT03170882 · FLOW

Participant flow

A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma · Source last updated 2022-12-20

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

groups
  1. description
    Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
    id
    FG000
    title
    Pomalidomide 4 mg + Dexamethasone 40 mg
  2. description
    Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
    id
    FG001
    title
    Ixazomib 4 mg + Dexamethasone 20 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        29
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        36
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        73
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        47
      2. group Id
        FG001
        num Subjects
        72
      comment
      Safety Population included all participants who received at least 1 dose of any study drug.
      type
      Treated: Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        70
      comment
      Intent-to-Treat Patient Reported Outcomes (ITT PRO) Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L).
      type
      ITT PRO Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        73
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with a diagnosis of relapsed and/or refractory multiple myeloma (RRMM) who received at least 2 prior lines of therapy were enrolled in 2:3 ratio to receive pomalidomide + dexamethasone or ixazomib + dexamethasone in this study.
recruitment Details
Participants took part in the study at 54 investigative sites in Australia, Turkey, Czech Republic, France, Germany, Italy, Netherlands, Norway, Spain, Israel, United Kingdom, Sweden, Greece, and Russian Federation from 01 August 2017 up to 26 November 2021.
Complete source fields
groups
  1. description
    Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
    id
    FG000
    title
    Pomalidomide 4 mg + Dexamethasone 40 mg
  2. description
    Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
    id
    FG001
    title
    Ixazomib 4 mg + Dexamethasone 20 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        29
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        36
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        73
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        47
      2. group Id
        FG001
        num Subjects
        72
      comment
      Safety Population included all participants who received at least 1 dose of any study drug.
      type
      Treated: Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        70
      comment
      Intent-to-Treat Patient Reported Outcomes (ITT PRO) Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L).
      type
      ITT PRO Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        73
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with a diagnosis of relapsed and/or refractory multiple myeloma (RRMM) who received at least 2 prior lines of therapy were enrolled in 2:3 ratio to receive pomalidomide + dexamethasone or ixazomib + dexamethasone in this study.
recruitment Details
Participants took part in the study at 54 investigative sites in Australia, Turkey, Czech Republic, France, Germany, Italy, Netherlands, Norway, Spain, Israel, United Kingdom, Sweden, Greece, and Russian Federation from 01 August 2017 up to 26 November 2021.

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Preserved source evidence · Not medical advice