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NCT00843882 · FLOW

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Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia · Source last updated 2026-09-02

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

groups
  1. description
    Patients receive lenalidomide PO QD on days 1-21.
    id
    FG000
    title
    Arm A (Lenalidomide; Chromosome 5q31.1 Deletion)
  2. description
    Patients receive lenalidomide PO QD on days 1-21.
    id
    FG001
    title
    Arm A (Lenalidomide; Randomization)
  3. description
    Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
    id
    FG002
    title
    Arm B (Lenalidomide + Epoetin Alfa; Randomization)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        21
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        20
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        9
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Patient and physician's decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      type
      Other complicating disease
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Alternative therapy
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Patient switched treatment early due to DSMC announcement
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      type
      Off treatment reason unknown
    11. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Never started treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        103
      3. group Id
        FG002
        num Subjects
        106
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        103
      3. group Id
        FG002
        num Subjects
        106
      type
      Treated Patients
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        96
      3. group Id
        FG002
        num Subjects
        99
      type
      Evaluable Patients Included in Primary Analysis
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        51
      type
      Patients With Cytogenetic Response Data Available
    5. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        48
      3. group Id
        FG002
        num Subjects
        41
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        65
      type
      NOT COMPLETED
    title
    Step 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Alternative treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Prolonged wound healing
    milestones
    1. achievements
      1. comment
        All patients in Arm A that did not achieve major erythroid response (MER) were offered to receive combined treatment in Step 2.
        group Id
        FG000
        num Subjects
        7
      2. comment
        All patients in Arm A that did not achieve major erythroid response (MER) were offered to receive combined treatment in Step 2.
        group Id
        FG001
        num Subjects
        46
      3. comment
        Only patients in Arm A that did not achieve major erythroid response (MER) were offered to receive combined treatment in Step 2.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        0
      type
      Evaluable Patients Included in Primary Analysis
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 2 (Cross-over to Arm B)
recruitment Details
From April 2009 through May 2016, the trial enrolled a total of 247 patients.
Complete source fields
groups
  1. description
    Patients receive lenalidomide PO QD on days 1-21.
    id
    FG000
    title
    Arm A (Lenalidomide; Chromosome 5q31.1 Deletion)
  2. description
    Patients receive lenalidomide PO QD on days 1-21.
    id
    FG001
    title
    Arm A (Lenalidomide; Randomization)
  3. description
    Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
    id
    FG002
    title
    Arm B (Lenalidomide + Epoetin Alfa; Randomization)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        21
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        20
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        9
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Patient and physician's decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      type
      Other complicating disease
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Alternative therapy
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Patient switched treatment early due to DSMC announcement
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      type
      Off treatment reason unknown
    11. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Never started treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        103
      3. group Id
        FG002
        num Subjects
        106
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        103
      3. group Id
        FG002
        num Subjects
        106
      type
      Treated Patients
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        96
      3. group Id
        FG002
        num Subjects
        99
      type
      Evaluable Patients Included in Primary Analysis
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        51
      type
      Patients With Cytogenetic Response Data Available
    5. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        48
      3. group Id
        FG002
        num Subjects
        41
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        65
      type
      NOT COMPLETED
    title
    Step 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Alternative treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Prolonged wound healing
    milestones
    1. achievements
      1. comment
        All patients in Arm A that did not achieve major erythroid response (MER) were offered to receive combined treatment in Step 2.
        group Id
        FG000
        num Subjects
        7
      2. comment
        All patients in Arm A that did not achieve major erythroid response (MER) were offered to receive combined treatment in Step 2.
        group Id
        FG001
        num Subjects
        46
      3. comment
        Only patients in Arm A that did not achieve major erythroid response (MER) were offered to receive combined treatment in Step 2.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        0
      type
      Evaluable Patients Included in Primary Analysis
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 2 (Cross-over to Arm B)
recruitment Details
From April 2009 through May 2016, the trial enrolled a total of 247 patients.

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

Preserved source evidence · Not medical advice