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NCT00872521 · FLOW

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A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma · Source last updated 2014-05-16

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

groups
  1. description
    Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    FG000
    title
    1q21 Amplified
  2. description
    Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    FG001
    title
    1q21 Not Amplified
  3. description
    Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    FG002
    title
    Failed/Missing Test
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Patient choice
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. comment
        Received allocated treatment
        group Id
        FG000
        num Subjects
        26
      2. comment
        Received allocated treatment
        group Id
        FG001
        num Subjects
        72
      3. comment
        Received allocated treatment
        group Id
        FG002
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. comment
        Completed PAD induction
        group Id
        FG000
        num Subjects
        21
      2. comment
        Completed PAD induction
        group Id
        FG001
        num Subjects
        68
      3. comment
        Completed PAD induction
        group Id
        FG002
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Completed PAD Induction
  2. 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
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Patient choice
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Efficacy data unavailable
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Patient response missing
    milestones
    1. achievements
      1. comment
        Completed PAD induction
        group Id
        FG000
        num Subjects
        21
      2. comment
        Completed PAD induction
        group Id
        FG001
        num Subjects
        68
      3. comment
        Completed PAD induction
        group Id
        FG002
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. comment
        participants analyzed
        group Id
        FG000
        num Subjects
        20
      2. comment
        participants analyzed
        group Id
        FG001
        num Subjects
        63
      3. comment
        participants analyzed
        group Id
        FG002
        num Subjects
        8
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Primary Endpoint Analysis
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    milestones
    1. achievements
      1. comment
        Participants analyzed for primary endpoint
        group Id
        FG000
        num Subjects
        20
      2. comment
        Participants analyzed for primary endpoint
        group Id
        FG001
        num Subjects
        63
      3. comment
        Participants analyzed for primary endpoint
        group Id
        FG002
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. comment
        Completed 3-month follow-up
        group Id
        FG000
        num Subjects
        20
      2. comment
        Completed 3-month follow-up
        group Id
        FG001
        num Subjects
        60
      3. comment
        Completed 3-month follow-up
        group Id
        FG002
        num Subjects
        8
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Completed 3-month Follow up
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Efficacy data unavailable
    milestones
    1. achievements
      1. comment
        Completed 3-month follow-up
        group Id
        FG000
        num Subjects
        20
      2. comment
        Completed 3-month follow-up
        group Id
        FG001
        num Subjects
        60
      3. comment
        Completed 3-month follow-up
        group Id
        FG002
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. comment
        Participants analyzed for secondary endpoint
        group Id
        FG000
        num Subjects
        20
      2. comment
        Participants analyzed for secondary endpoint
        group Id
        FG001
        num Subjects
        58
      3. comment
        Participants analyzed for secondary endpoint
        group Id
        FG002
        num Subjects
        7
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Secondary Endpoint Analysis
pre Assignment Details
107 participants were enrolled and they all received the study treatment.
recruitment Details
The participants were enrolled at multiple sites in Australia
Complete source fields
groups
  1. description
    Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    FG000
    title
    1q21 Amplified
  2. description
    Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    FG001
    title
    1q21 Not Amplified
  3. description
    Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    FG002
    title
    Failed/Missing Test
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Patient choice
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. comment
        Received allocated treatment
        group Id
        FG000
        num Subjects
        26
      2. comment
        Received allocated treatment
        group Id
        FG001
        num Subjects
        72
      3. comment
        Received allocated treatment
        group Id
        FG002
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. comment
        Completed PAD induction
        group Id
        FG000
        num Subjects
        21
      2. comment
        Completed PAD induction
        group Id
        FG001
        num Subjects
        68
      3. comment
        Completed PAD induction
        group Id
        FG002
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Completed PAD Induction
  2. 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
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Patient choice
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Efficacy data unavailable
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Patient response missing
    milestones
    1. achievements
      1. comment
        Completed PAD induction
        group Id
        FG000
        num Subjects
        21
      2. comment
        Completed PAD induction
        group Id
        FG001
        num Subjects
        68
      3. comment
        Completed PAD induction
        group Id
        FG002
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. comment
        participants analyzed
        group Id
        FG000
        num Subjects
        20
      2. comment
        participants analyzed
        group Id
        FG001
        num Subjects
        63
      3. comment
        participants analyzed
        group Id
        FG002
        num Subjects
        8
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Primary Endpoint Analysis
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    milestones
    1. achievements
      1. comment
        Participants analyzed for primary endpoint
        group Id
        FG000
        num Subjects
        20
      2. comment
        Participants analyzed for primary endpoint
        group Id
        FG001
        num Subjects
        63
      3. comment
        Participants analyzed for primary endpoint
        group Id
        FG002
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. comment
        Completed 3-month follow-up
        group Id
        FG000
        num Subjects
        20
      2. comment
        Completed 3-month follow-up
        group Id
        FG001
        num Subjects
        60
      3. comment
        Completed 3-month follow-up
        group Id
        FG002
        num Subjects
        8
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Completed 3-month Follow up
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Efficacy data unavailable
    milestones
    1. achievements
      1. comment
        Completed 3-month follow-up
        group Id
        FG000
        num Subjects
        20
      2. comment
        Completed 3-month follow-up
        group Id
        FG001
        num Subjects
        60
      3. comment
        Completed 3-month follow-up
        group Id
        FG002
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. comment
        Participants analyzed for secondary endpoint
        group Id
        FG000
        num Subjects
        20
      2. comment
        Participants analyzed for secondary endpoint
        group Id
        FG001
        num Subjects
        58
      3. comment
        Participants analyzed for secondary endpoint
        group Id
        FG002
        num Subjects
        7
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Secondary Endpoint Analysis
pre Assignment Details
107 participants were enrolled and they all received the study treatment.
recruitment Details
The participants were enrolled at multiple sites in Australia

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Preserved source evidence · Not medical advice