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NCT00179647 · FLOW

Participant flow

Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma · Source last updated 2010-03-16

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

groups
  1. description
    This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
    id
    FG000
    title
    Lenalidomide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        294
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        478
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        83
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        94
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        960
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1913
      type
      STARTED
    2. achievements
      1. comment
        Subjects participated in study until they presented with reason for discontinuation.
        group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1913
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
    id
    FG000
    title
    Lenalidomide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        294
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        478
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        83
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        94
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        960
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1913
      type
      STARTED
    2. achievements
      1. comment
        Subjects participated in study until they presented with reason for discontinuation.
        group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1913
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice