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NCT01539083 · FLOW

Participant flow

Velcade (Bortezomib) Consolidation After Transplant · Source last updated 2025-02-04

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

groups
  1. description
    Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
    id
    FG000
    title
    Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)
  2. description
    Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
    id
    FG001
    title
    Thalidomide + Prednisolone (TP Consolidation)
  3. description
    Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
    id
    FG002
    title
    Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        256
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        254
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        203
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Before Randomization (VCD Induction)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        3
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        11
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        Participants who completed induction phase were randomized for the consolidated treatment.
        group Id
        FG001
        num Subjects
        100
      3. comment
        Participants who completed induction phase were randomized for the consolidation treatment phase.
        group Id
        FG002
        num Subjects
        103
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        One participant was randomized but not treated. Hence, was not included in safety population.
        group Id
        FG001
        num Subjects
        99
      3. group Id
        FG002
        num Subjects
        103
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        79
      3. group Id
        FG002
        num Subjects
        80
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        23
      type
      NOT COMPLETED
    title
    After Randomization (TP and VTP)
pre Assignment Details
The study consisted of 2 treatment phases: induction and consolidation. Participants who completed the induction phase were randomized to enter in the consolidation treatment phase.
Complete source fields
groups
  1. description
    Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
    id
    FG000
    title
    Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)
  2. description
    Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
    id
    FG001
    title
    Thalidomide + Prednisolone (TP Consolidation)
  3. description
    Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
    id
    FG002
    title
    Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        256
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        254
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        203
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Before Randomization (VCD Induction)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        3
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        11
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        Participants who completed induction phase were randomized for the consolidated treatment.
        group Id
        FG001
        num Subjects
        100
      3. comment
        Participants who completed induction phase were randomized for the consolidation treatment phase.
        group Id
        FG002
        num Subjects
        103
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        One participant was randomized but not treated. Hence, was not included in safety population.
        group Id
        FG001
        num Subjects
        99
      3. group Id
        FG002
        num Subjects
        103
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        79
      3. group Id
        FG002
        num Subjects
        80
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        23
      type
      NOT COMPLETED
    title
    After Randomization (TP and VTP)
pre Assignment Details
The study consisted of 2 treatment phases: induction and consolidation. Participants who completed the induction phase were randomized to enter in the consolidation treatment phase.

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Preserved source evidence · Not medical advice