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NCT00445692 · FLOW

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Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma · Source last updated 2019-11-13

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

groups
  1. description
    Patients receive clarithromycin orally twice daily and dexamethasone orally once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide orally once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin. NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks. Clarithromycin: Given Orally (PO) Dexamethasone: Given PO Lenalidomide: Given PO
    id
    FG000
    title
    Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Lack of Efficacy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
32 patients were enrolled. 31 patients started therapy. 1 patient was consented but was deemed ineligible prior to therapy initiation.
Complete source fields
groups
  1. description
    Patients receive clarithromycin orally twice daily and dexamethasone orally once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide orally once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin. NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks. Clarithromycin: Given Orally (PO) Dexamethasone: Given PO Lenalidomide: Given PO
    id
    FG000
    title
    Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Lack of Efficacy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
32 patients were enrolled. 31 patients started therapy. 1 patient was consented but was deemed ineligible prior to therapy initiation.

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Preserved source evidence · Not medical advice