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NCT03269552 · OUTCOME

Overall Response Rate

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

Descriptive statistics will be used for baseline characteristics, and responses to treatment.

Analysis population: Participants who were evaluated after cycle 2 day 15 and prior to cycle 3 day 1.

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

Complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Carfilzomib, Rituximab)0Not reportedNot reportedNot reportedNot reported
Very good partial response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Carfilzomib, Rituximab)0Not reportedNot reportedNot reportedNot reported
Partial response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Carfilzomib, Rituximab)2Not reportedNot reportedNot reportedNot reported
Minor response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Carfilzomib, Rituximab)1Not reportedNot reportedNot reportedNot reported
Stable disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Carfilzomib, Rituximab)1Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Carfilzomib, Rituximab)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Very good partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Partial response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Minor response
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Stable disease
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Progressive disease
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Descriptive statistics will be used for baseline characteristics, and responses to treatment.
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
COUNT_OF_PARTICIPANTS
population Description
Participants who were evaluated after cycle 2 day 15 and prior to cycle 3 day 1.
reporting Status
POSTED
time Frame
Up to 1 year
title
Overall Response Rate
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice