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NCT00492050 · OUTCOME

Response Rate After 2 Cycles of Treatment With Bortezomib and Rituximab

Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia · Source last updated 2026-03-11

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
After 2 (35 day) cycles of treatment

What was measured

Partial response (PR) defined as at least \> 50 % reduction of serum monoclonal IgM concentration determined by protein electrophoresis, \> 50% decrease in adenopathy / organomegaly on physical examination or on CT scan, and no new symptoms or signs of active disease. Complete response (CR) defined as a disappearance of serum and urine monoclonal protein determined by immunofixation, absence of malignant cells in bone marrow determined by histologic evaluation, resolution of adenopathy/organomegaly (confirmed by computed tomography \[CT\] scan), and no signs or symptoms attributable to WM. Stable disease defined as neither grown nor shrunk; the amount of disease has not changed.Participants will be followed for \< 6 months after receiving bortezomib/rituximab or rituximab-modified hyper-CVAD to be considered unresponsive to therapy in accordance with the guidelines of the Consensus Panel of the Third International Workshop on Waldenstrom's Macroglobulinemia.

Analysis population: 1 subject didn't complete 2 cycles of therapy and isn't evaluable for response

Groups in this outcome

All Participants

Bortezomib 1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m\^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily). Bortezomib: 1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab: 375 mg/m\^2 IV on Day 8 and 22. Valacyclovir: 500 mg orally daily (or acyclovir 200 mg orally twice daily)

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

Analysis denominator · Participants

GroupSource count
All Participants36

Reported measurements

Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants20Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants11Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants2Not reportedNot reportedNot reportedNot reported
No Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Stable Disease
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Progressive Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    No Response
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    units
    Participants
description
Partial response (PR) defined as at least \> 50 % reduction of serum monoclonal IgM concentration determined by protein electrophoresis, \> 50% decrease in adenopathy / organomegaly on physical examination or on CT scan, and no new symptoms or signs of active disease. Complete response (CR) defined as a disappearance of serum and urine monoclonal protein determined by immunofixation, absence of malignant cells in bone marrow determined by histologic evaluation, resolution of adenopathy/organomegaly (confirmed by computed tomography \[CT\] scan), and no signs or symptoms attributable to WM. Stable disease defined as neither grown nor shrunk; the amount of disease has not changed.Participants will be followed for \< 6 months after receiving bortezomib/rituximab or rituximab-modified hyper-CVAD to be considered unresponsive to therapy in accordance with the guidelines of the Consensus Panel of the Third International Workshop on Waldenstrom's Macroglobulinemia.
groups
  1. description
    Bortezomib 1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m\^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily). Bortezomib: 1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab: 375 mg/m\^2 IV on Day 8 and 22. Valacyclovir: 500 mg orally daily (or acyclovir 200 mg orally twice daily)
    id
    OG000
    title
    All Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
1 subject didn't complete 2 cycles of therapy and isn't evaluable for response
reporting Status
POSTED
time Frame
After 2 (35 day) cycles of treatment
title
Response Rate After 2 Cycles of Treatment With Bortezomib and Rituximab
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice