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NCT02917941 · FLOW

Participant flow

A Study of Ixazomib Plus Lenalidomide and Dexamethasone in Adult Japanese Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2021-01-12

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 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
    id
    FG000
    title
    Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        34
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      comment
      Out of 34 Participants, 31 entered the Follow-up Period.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Survival Follow-up Period
pre Assignment Details
Participants with confirmed MM, who received 1-3 lines of prior therapy, received ixazomib 4 mg + lenalidomide and dexamethasone in this study, followed by progression free survival (PFS) and overall survival (OS) follow-up.
recruitment Details
Participants took part in the study at 16 investigative sites in Japan from 01 November 2016 to 31 August 2019.
Complete source fields
groups
  1. description
    Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
    id
    FG000
    title
    Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        34
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      comment
      Out of 34 Participants, 31 entered the Follow-up Period.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Survival Follow-up Period
pre Assignment Details
Participants with confirmed MM, who received 1-3 lines of prior therapy, received ixazomib 4 mg + lenalidomide and dexamethasone in this study, followed by progression free survival (PFS) and overall survival (OS) follow-up.
recruitment Details
Participants took part in the study at 16 investigative sites in Japan from 01 November 2016 to 31 August 2019.

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Preserved source evidence · Not medical advice