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NCT00644228 · FLOW

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Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma · Source last updated 2026-07-29

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

groups
  1. description
    Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    FG000
    title
    Arm I (Dexamethasone and Lenalidomide)
  2. description
    Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    FG001
    title
    Arm II (Dexamethasone, Lenalidomide, Bortezomib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        21
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrew Consent prior to therapy start
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Invalid Consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        261
      2. group Id
        FG001
        num Subjects
        264
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        229
      2. group Id
        FG001
        num Subjects
        242
      comment
      All patients who were consented and did not withdraw consent prior to treatment are "Analyzable".
      type
      Eligible and Analyzable
    3. achievements
      1. group Id
        FG000
        num Subjects
        229
      2. group Id
        FG001
        num Subjects
        242
      comment
      "Completed" does not apply to this study period.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        22
      type
      NOT COMPLETED
    title
    Randomization & Eligibility
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        55
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        12
      type
      Progression/Relapse
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        7
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        28
      type
      Not Protocol-Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        229
      2. group Id
        FG001
        num Subjects
        242
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        146
      2. group Id
        FG001
        num Subjects
        137
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        83
      2. group Id
        FG001
        num Subjects
        105
      type
      NOT COMPLETED
    title
    Induction Therapy
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        31
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        42
      type
      Progression/Relapse
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        15
      type
      Not Protocol-Specified
    6. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        40
      type
      On Treatment
    milestones
    1. achievements
      1. comment
        3 patients who completed induction did not continue on to maintenance due to refusal (1), other (2).
        group Id
        FG000
        num Subjects
        143
      2. comment
        2 patients who completed induction did not continue on to maintenance due to other (2).
        group Id
        FG001
        num Subjects
        135
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Patients were treated until progression or removal/refusal. "Completed" does not apply.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        143
      2. group Id
        FG001
        num Subjects
        135
      type
      NOT COMPLETED
    title
    Maintenance
Complete source fields
groups
  1. description
    Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    FG000
    title
    Arm I (Dexamethasone and Lenalidomide)
  2. description
    Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    FG001
    title
    Arm II (Dexamethasone, Lenalidomide, Bortezomib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        21
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrew Consent prior to therapy start
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Invalid Consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        261
      2. group Id
        FG001
        num Subjects
        264
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        229
      2. group Id
        FG001
        num Subjects
        242
      comment
      All patients who were consented and did not withdraw consent prior to treatment are "Analyzable".
      type
      Eligible and Analyzable
    3. achievements
      1. group Id
        FG000
        num Subjects
        229
      2. group Id
        FG001
        num Subjects
        242
      comment
      "Completed" does not apply to this study period.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        22
      type
      NOT COMPLETED
    title
    Randomization & Eligibility
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        55
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        12
      type
      Progression/Relapse
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        7
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        28
      type
      Not Protocol-Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        229
      2. group Id
        FG001
        num Subjects
        242
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        146
      2. group Id
        FG001
        num Subjects
        137
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        83
      2. group Id
        FG001
        num Subjects
        105
      type
      NOT COMPLETED
    title
    Induction Therapy
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        31
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        42
      type
      Progression/Relapse
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        15
      type
      Not Protocol-Specified
    6. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        40
      type
      On Treatment
    milestones
    1. achievements
      1. comment
        3 patients who completed induction did not continue on to maintenance due to refusal (1), other (2).
        group Id
        FG000
        num Subjects
        143
      2. comment
        2 patients who completed induction did not continue on to maintenance due to other (2).
        group Id
        FG001
        num Subjects
        135
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Patients were treated until progression or removal/refusal. "Completed" does not apply.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        143
      2. group Id
        FG001
        num Subjects
        135
      type
      NOT COMPLETED
    title
    Maintenance

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

Preserved source evidence · Not medical advice