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NCT02002598 · FLOW

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Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma · Source last updated 2024-09-19

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

groups
  1. description
    Participants will receive 27 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 70 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
    id
    FG000
    title
    Carfilzomib 27 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg
  2. description
    Participants will receive 36 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 70 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
    id
    FG001
    title
    Carfilzomib 36 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg
  3. description
    Participants will receive 36 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
    id
    FG002
    title
    Carfilzomib 36 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
  4. description
    Participants will receive 45 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
    id
    FG003
    title
    Carfilzomib 45 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
  5. description
    Participants will receive 56 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
    id
    FG004
    title
    Carfilzomib 56 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 1
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 2
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 3
  4. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 4
  5. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 5
pre Assignment Details
23 participants signed a consent form; 2 were screen fails and 1 was removed from the study prior to the study start and did not receive the study interventions.
Complete source fields
groups
  1. description
    Participants will receive 27 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 70 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
    id
    FG000
    title
    Carfilzomib 27 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg
  2. description
    Participants will receive 36 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 70 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
    id
    FG001
    title
    Carfilzomib 36 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg
  3. description
    Participants will receive 36 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
    id
    FG002
    title
    Carfilzomib 36 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
  4. description
    Participants will receive 45 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
    id
    FG003
    title
    Carfilzomib 45 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
  5. description
    Participants will receive 56 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
    id
    FG004
    title
    Carfilzomib 56 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 1
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 2
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 3
  4. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 4
  5. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 5
pre Assignment Details
23 participants signed a consent form; 2 were screen fails and 1 was removed from the study prior to the study start and did not receive the study interventions.

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Preserved source evidence · Not medical advice