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NCT00064038 · FLOW

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S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma · Source last updated 2015-03-25

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

groups
  1. description
    Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Lenalidomide+Dexamethasone
  2. description
    Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
    id
    FG001
    title
    Dexamethasone
  3. description
    Patients who have progressive or relapsed disease or who experience unacceptable toxicity attributable to dexamethasone dosing level -2 while on blinded treatment, will be unblinded. Patients shown to have been randomized to DEX + Placebo will proceed with crossover registration and Open-Label Induction with DEX + CC-5013or with open-label CC-5013 alone if they are unblinded due to dexamethasone toxicity. Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    FG002
    title
    Crossover to Lenalidomide+Dexamethasone
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        98
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        97
      2. group Id
        FG001
        num Subjects
        95
      3. group Id
        FG002
        num Subjects
        0
      type
      Eligible and Analyzable
    3. achievements
      1. group Id
        FG000
        num Subjects
        96
      2. group Id
        FG001
        num Subjects
        94
      3. group Id
        FG002
        num Subjects
        0
      type
      Safety Population
    4. achievements
      1. comment
        The study was closed early per recommedation of the Data Safety Monitoring Committee.
        group Id
        FG000
        num Subjects
        0
      2. comment
        The study was closed early per recommedation of the Data Safety Monitoring Committee.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        98
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Initial Randomization
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        See Crossover to Lenalidomide+Dexamethasone Arm.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        42
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        See Crossover to Lenalidomide+Dexamethasone Arm.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        40
      type
      Eligible and Analyzable
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        See Crossover to Lenalidomide+Dexamethasone Arm.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        40
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        See Crossover to Lenalidomide+Dexamethasone Arm.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        40
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Crossover to Lenalidomide+Dexamethasone
recruitment Details
Between October 15, 2004 and April 2, 2007, 198 patients were enrolled at 41 cooperative medical institutions.
Complete source fields
groups
  1. description
    Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Lenalidomide+Dexamethasone
  2. description
    Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
    id
    FG001
    title
    Dexamethasone
  3. description
    Patients who have progressive or relapsed disease or who experience unacceptable toxicity attributable to dexamethasone dosing level -2 while on blinded treatment, will be unblinded. Patients shown to have been randomized to DEX + Placebo will proceed with crossover registration and Open-Label Induction with DEX + CC-5013or with open-label CC-5013 alone if they are unblinded due to dexamethasone toxicity. Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    FG002
    title
    Crossover to Lenalidomide+Dexamethasone
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        98
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        97
      2. group Id
        FG001
        num Subjects
        95
      3. group Id
        FG002
        num Subjects
        0
      type
      Eligible and Analyzable
    3. achievements
      1. group Id
        FG000
        num Subjects
        96
      2. group Id
        FG001
        num Subjects
        94
      3. group Id
        FG002
        num Subjects
        0
      type
      Safety Population
    4. achievements
      1. comment
        The study was closed early per recommedation of the Data Safety Monitoring Committee.
        group Id
        FG000
        num Subjects
        0
      2. comment
        The study was closed early per recommedation of the Data Safety Monitoring Committee.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        98
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Initial Randomization
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        See Crossover to Lenalidomide+Dexamethasone Arm.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        42
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        See Crossover to Lenalidomide+Dexamethasone Arm.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        40
      type
      Eligible and Analyzable
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        See Crossover to Lenalidomide+Dexamethasone Arm.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        40
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        See Crossover to Lenalidomide+Dexamethasone Arm.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        40
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Crossover to Lenalidomide+Dexamethasone
recruitment Details
Between October 15, 2004 and April 2, 2007, 198 patients were enrolled at 41 cooperative medical institutions.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice