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NCT00215943 · FLOW

Participant flow

Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD) · Source last updated 2014-04-17

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

groups
  1. description
    VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle.
    id
    FG000
    title
    Active Comparator: VAD Treatment
  2. description
    Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
    id
    FG001
    title
    Active Comparator: Thalidomide and Dexamethasone Treatment
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Alternate therapy
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Other disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Other complications
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        37
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
90 participants were consented. 83 were eligible and randomized to treatment arms. 2 became ineligible after randomization and prior to treatment. 8 withdrew prior to treatment. 73 began treatment.
recruitment Details
Recruitment began at Moffitt Cancer Center in June of 2003 and ended prematurely in December of 2007.
Complete source fields
groups
  1. description
    VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle.
    id
    FG000
    title
    Active Comparator: VAD Treatment
  2. description
    Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
    id
    FG001
    title
    Active Comparator: Thalidomide and Dexamethasone Treatment
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Alternate therapy
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Other disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Other complications
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        37
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
90 participants were consented. 83 were eligible and randomized to treatment arms. 2 became ineligible after randomization and prior to treatment. 8 withdrew prior to treatment. 73 began treatment.
recruitment Details
Recruitment began at Moffitt Cancer Center in June of 2003 and ended prematurely in December of 2007.

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Preserved source evidence · Not medical advice