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NCT02477215 · FLOW

Participant flow

Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma · Source last updated 2020-10-22

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

groups
  1. description
    MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 70 mg/m\^2 days 1 and 2
    id
    FG000
    title
    Bendamustine (70 mg/m^2), MLN9708, Dexamethasone
  2. description
    MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 80 mg/m\^2 days 1 and 2
    id
    FG001
    title
    Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
  3. description
    MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 90 mg/m\^2 days 1 and 2
    id
    FG002
    title
    Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Escalation Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    milestones
    1. achievements
      1. comment
        No subjects were started in this group as it was not the optimal dose.
        group Id
        FG000
        num Subjects
        0
      2. comment
        Subjects in Period 1 did not continue into Period 2. This is a new subject population.
        group Id
        FG001
        num Subjects
        20
      3. comment
        No subjects were started in this group as it was not the optimal dose.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Fixed Dose Phase
Complete source fields
groups
  1. description
    MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 70 mg/m\^2 days 1 and 2
    id
    FG000
    title
    Bendamustine (70 mg/m^2), MLN9708, Dexamethasone
  2. description
    MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 80 mg/m\^2 days 1 and 2
    id
    FG001
    title
    Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
  3. description
    MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 90 mg/m\^2 days 1 and 2
    id
    FG002
    title
    Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Escalation Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    milestones
    1. achievements
      1. comment
        No subjects were started in this group as it was not the optimal dose.
        group Id
        FG000
        num Subjects
        0
      2. comment
        Subjects in Period 1 did not continue into Period 2. This is a new subject population.
        group Id
        FG001
        num Subjects
        20
      3. comment
        No subjects were started in this group as it was not the optimal dose.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Fixed Dose Phase

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Preserved source evidence · Not medical advice