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NCT01734928 · FLOW

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Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-06-06

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

groups
  1. description
    POM (Pomalidomide) * 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
    id
    FG000
    title
    Treatment 1: POM+BTZ+LD-DEX
  2. description
    BTZ ((Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
    id
    FG001
    title
    Treatment 2: BTZ+LD-DEX
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      clinical progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      progressive disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Withdrew informed consent
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Randomization error
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        281
      2. group Id
        FG001
        num Subjects
        278
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        278
      2. group Id
        FG001
        num Subjects
        270
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Randomization
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        167
      2. group Id
        FG001
        num Subjects
        165
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        52
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        22
      type
      Withdrawal of Consent
    5. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        9
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        19
      type
      Other Reasons
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Pregnancy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        278
      2. group Id
        FG001
        num Subjects
        270
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        278
      2. group Id
        FG001
        num Subjects
        270
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
548 participants treated
Complete source fields
groups
  1. description
    POM (Pomalidomide) * 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
    id
    FG000
    title
    Treatment 1: POM+BTZ+LD-DEX
  2. description
    BTZ ((Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
    id
    FG001
    title
    Treatment 2: BTZ+LD-DEX
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      clinical progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      progressive disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Withdrew informed consent
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Randomization error
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        281
      2. group Id
        FG001
        num Subjects
        278
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        278
      2. group Id
        FG001
        num Subjects
        270
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Randomization
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        167
      2. group Id
        FG001
        num Subjects
        165
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        52
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        22
      type
      Withdrawal of Consent
    5. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        9
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        19
      type
      Other Reasons
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Pregnancy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        278
      2. group Id
        FG001
        num Subjects
        270
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        278
      2. group Id
        FG001
        num Subjects
        270
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
548 participants treated

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Preserved source evidence · Not medical advice