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NCT02020941 · FLOW

Participant flow

Carfilzomib in Treating Patients With Multiple Myeloma in First Relapse or Refractory to First-Line Therapy · Source last updated 2016-11-02

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

groups
  1. description
    TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8. MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. carfilzomib: Given IV dexamethasone: Given IV or PO laboratory biomarker analysis: Correlative studies
    id
    FG000
    title
    Treatment (Carfilzomib, Dexamethasone)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This protocol was based on enrolling 23 patients. Due to slow accrual, the study was closed with 10 patients enrolled.
Complete source fields
groups
  1. description
    TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8. MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. carfilzomib: Given IV dexamethasone: Given IV or PO laboratory biomarker analysis: Correlative studies
    id
    FG000
    title
    Treatment (Carfilzomib, Dexamethasone)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This protocol was based on enrolling 23 patients. Due to slow accrual, the study was closed with 10 patients enrolled.

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Preserved source evidence · Not medical advice