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NCT03269552 · FLOW

Participant flow

Carfilzomib With or Without Rituximab in the Treatment of Waldenstrom Macroglobulinemia or Marginal Zone Lymphoma · Source last updated 2020-01-18

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

groups
  1. description
    Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib will continue to receive carfolzomib for 4 more courses. In addition, they will also receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity. Carfilzomib: Given IV Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
    id
    FG000
    title
    Treatment (Carfilzomib, Rituximab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
4 participants signed informed consent, met eligibility and continued on to study treatment.
Complete source fields
groups
  1. description
    Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib will continue to receive carfolzomib for 4 more courses. In addition, they will also receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity. Carfilzomib: Given IV Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
    id
    FG000
    title
    Treatment (Carfilzomib, Rituximab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
4 participants signed informed consent, met eligibility and continued on to study treatment.

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

Preserved source evidence · Not medical advice