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NCT01311687 · FLOW

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A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study · Source last updated 2018-10-24

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

groups
  1. description
    Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
    id
    FG000
    title
    Pomalidomide Plus Low-Dose Dexamethasone
  2. description
    Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
    id
    FG001
    title
    High-Dose Dexamethasone (HD-Dex)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        302
      2. group Id
        FG001
        num Subjects
        153
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        300
      2. group Id
        FG001
        num Subjects
        150
      type
      Received Study Drug
    3. achievements
      1. comment
        Not applicable to participants initially randomized to receive pomalidomide
        group Id
        FG000
        num Subjects
        0
      2. comment
        After Amendment 4 participants still on HD-Dex treatment were permitted to crossover to pomalidomide
        group Id
        FG001
        num Subjects
        11
      type
      Crossed-over to Pomalidomide
    4. achievements
      1. group Id
        FG000
        num Subjects
        302
      2. group Id
        FG001
        num Subjects
        153
      comment
      Completed represents participants who discontinued from study treatment
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Phase
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        0
      comment
      After Amendment 4 participants still on HD-Dex treatment were permitted to crossover to pomalidomide
      type
      Crossed-over to Pomalidomide
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        8
      comment
      Completed represents participants who discontinued from PFS follow-up
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    PFS Follow-up Phase
pre Assignment Details
Participants were randomized in a 2:1 ratio. Treatment phase discontinuation occurred when a participant had confirmed progressive disease. Participants who did not progress but who were intolerant to treatment, or no longer wished to receive study treatment entered the progression-free survival (PFS) follow-up period until disease progression.
recruitment Details
The study was conducted at 93 sites: 68 sites in Europe, 10 sites in Australia, 10 sites in Canada, 4 sites in Russia, and 1 site in the United States (US) from 18 March 2011 to 29 August 2017.
Complete source fields
groups
  1. description
    Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
    id
    FG000
    title
    Pomalidomide Plus Low-Dose Dexamethasone
  2. description
    Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
    id
    FG001
    title
    High-Dose Dexamethasone (HD-Dex)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        302
      2. group Id
        FG001
        num Subjects
        153
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        300
      2. group Id
        FG001
        num Subjects
        150
      type
      Received Study Drug
    3. achievements
      1. comment
        Not applicable to participants initially randomized to receive pomalidomide
        group Id
        FG000
        num Subjects
        0
      2. comment
        After Amendment 4 participants still on HD-Dex treatment were permitted to crossover to pomalidomide
        group Id
        FG001
        num Subjects
        11
      type
      Crossed-over to Pomalidomide
    4. achievements
      1. group Id
        FG000
        num Subjects
        302
      2. group Id
        FG001
        num Subjects
        153
      comment
      Completed represents participants who discontinued from study treatment
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Phase
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        0
      comment
      After Amendment 4 participants still on HD-Dex treatment were permitted to crossover to pomalidomide
      type
      Crossed-over to Pomalidomide
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        8
      comment
      Completed represents participants who discontinued from PFS follow-up
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    PFS Follow-up Phase
pre Assignment Details
Participants were randomized in a 2:1 ratio. Treatment phase discontinuation occurred when a participant had confirmed progressive disease. Participants who did not progress but who were intolerant to treatment, or no longer wished to receive study treatment entered the progression-free survival (PFS) follow-up period until disease progression.
recruitment Details
The study was conducted at 93 sites: 68 sites in Europe, 10 sites in Australia, 10 sites in Canada, 4 sites in Russia, and 1 site in the United States (US) from 18 March 2011 to 29 August 2017.

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Preserved source evidence · Not medical advice