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NCT00422799 · OUTCOME

Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated Waldenstrom's Macroglobulinemia (WM)

Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM) · Source last updated 2020-10-27

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
2 years

What was measured

Overall Response Rate= Minor response (\>25%-50% reduction in monoclonal IgM from baseline + Partial Response (\>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)

Analysis population: Participants who were previously untreated.

Groups in this outcome

Bortezomib and Rituximab

bortezomib and rituximab Bortezomib: Once weekly for 3 weeks Rituximab: Intravenously once a week for the first and fourth weeks of a cycle

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

Analysis denominator · Participants

GroupSource count
Bortezomib and Rituximab26

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib and Rituximab23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        23
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
Overall Response Rate= Minor response (\>25%-50% reduction in monoclonal IgM from baseline + Partial Response (\>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)
groups
  1. description
    bortezomib and rituximab Bortezomib: Once weekly for 3 weeks Rituximab: Intravenously once a week for the first and fourth weeks of a cycle
    id
    OG000
    title
    Bortezomib and Rituximab
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who were previously untreated.
reporting Status
POSTED
time Frame
2 years
title
Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated Waldenstrom's Macroglobulinemia (WM)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice