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NCT00511238 · FLOW

Participant flow

Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma · Source last updated 2017-08-31

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

groups
  1. description
    Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles
    id
    FG000
    title
    Carfilzomib (A0)
  2. description
    In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
    id
    FG001
    title
    Carfilzomib (A1)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        33
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        22
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        157
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        14
      type
      various reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        266
      type
      STARTED
    2. achievements
      1. comment
        Number of patients who completed 12 cycles of treatment
        group Id
        FG000
        num Subjects
        4
      2. comment
        Number of patients who completed 12 cycles of treatment
        group Id
        FG001
        num Subjects
        40
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        226
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Results of this study are reported in 2 parts, depending on whether a patient was enrolled and treated under the original protocol (referred to as 'A0') or under Amendment 1 and subsequent amendments (referred to as 'A1').
Complete source fields
groups
  1. description
    Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles
    id
    FG000
    title
    Carfilzomib (A0)
  2. description
    In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
    id
    FG001
    title
    Carfilzomib (A1)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        33
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        22
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        157
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        14
      type
      various reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        266
      type
      STARTED
    2. achievements
      1. comment
        Number of patients who completed 12 cycles of treatment
        group Id
        FG000
        num Subjects
        4
      2. comment
        Number of patients who completed 12 cycles of treatment
        group Id
        FG001
        num Subjects
        40
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        226
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Results of this study are reported in 2 parts, depending on whether a patient was enrolled and treated under the original protocol (referred to as 'A0') or under Amendment 1 and subsequent amendments (referred to as 'A1').

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Preserved source evidence · Not medical advice