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NCT03269552 · OUTCOME

Time to Progression

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.

Measure
MEDIAN
Unit
Months
Interval / dispersion
Standard Error
Time frame
Up to 1 year

What was measured

Estimated using Kaplan-Meier analysis.

Groups in this outcome

Treatment (Carfilzomib, Rituximab)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Carfilzomib, Rituximab)4

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Treatment (Carfilzomib, Rituximab)80.05Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.05
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Estimated using Kaplan-Meier analysis.
dispersion Type
Standard Error
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
    OG000
    title
    Treatment (Carfilzomib, Rituximab)
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 1 year
title
Time to Progression
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice