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NCT00833560 · FLOW

Participant flow

A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy · Source last updated 2014-11-21

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

groups
  1. description
    Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
    id
    FG000
    title
    Cyclophosphamide + Bortezomib + Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      type
      Toxicity
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Pregression of other disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        395
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        353
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        42
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Out of 401 participants, 399 participants were treated in both the Parts. Out of 399 participants, 395 participants were evaluated as 4 participants who had received cyclophophamide dose of greater than 1350 mg/m\^2 per cycle in Part 1 were excluded.
recruitment Details
401 participants were enrolled at 41 study sites in Germany.
Complete source fields
groups
  1. description
    Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
    id
    FG000
    title
    Cyclophosphamide + Bortezomib + Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      type
      Toxicity
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Pregression of other disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        395
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        353
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        42
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Out of 401 participants, 399 participants were treated in both the Parts. Out of 399 participants, 395 participants were evaluated as 4 participants who had received cyclophophamide dose of greater than 1350 mg/m\^2 per cycle in Part 1 were excluded.
recruitment Details
401 participants were enrolled at 41 study sites in Germany.

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Preserved source evidence · Not medical advice