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NCT01090921 · FLOW

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Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma · Source last updated 2020-09-09

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

groups
  1. description
    Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks. Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.
    id
    FG000
    title
    Bortezomib and Dexamethasone
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        50
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks. Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.
    id
    FG000
    title
    Bortezomib and Dexamethasone
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        50
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice