Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00250926 · OUTCOME

Response Rate

Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia · Source last updated 2016-04-08

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
33.2 months

What was measured

This outcome measure was to determine the response rate along with attainment of stable disease and time to disease progression following treatment with this patient population. The response rates were defined as follows. A complete response (CR) was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, absence of bone marrow disease by bone marrow biopsy and aspiration, and resolution of any adenopathy or splenomegaly. A near complete response (nCR) was defined as fulfilling all CR criteria in the presence of a positive immunofixation study. Patients with very good partial response (VGPR), partial response (PR), and minor response (MR) were defined as having a ≥ 90%, ≥ 50%, and 25% to 49% reduction in serum IgM levels, respectively. Progressive disease (PD) occurred when a more than 25% increase in serum IgM level or progression of clinically significant disease parameters was observed.

Analysis population: all enrolled patients

Groups in this outcome

Bortezomib, Dexamethasone, Rituximab

A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.

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, Dexamethasone, Rituximab23

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib, Dexamethasone, Rituximab3Not reportedNot reportedNot reportedNot reported
Near Complete Response (nCR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib, Dexamethasone, Rituximab2Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VGPR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib, Dexamethasone, Rituximab3Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib, Dexamethasone, Rituximab11Not reportedNot reportedNot reportedNot reported
Minor Response (MR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib, Dexamethasone, Rituximab3Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib, Dexamethasone, Rituximab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Near Complete Response (nCR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Very Good Partial Response (VGPR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Partial Response (PR)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Minor Response (MR)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Stable Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
This outcome measure was to determine the response rate along with attainment of stable disease and time to disease progression following treatment with this patient population. The response rates were defined as follows. A complete response (CR) was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, absence of bone marrow disease by bone marrow biopsy and aspiration, and resolution of any adenopathy or splenomegaly. A near complete response (nCR) was defined as fulfilling all CR criteria in the presence of a positive immunofixation study. Patients with very good partial response (VGPR), partial response (PR), and minor response (MR) were defined as having a ≥ 90%, ≥ 50%, and 25% to 49% reduction in serum IgM levels, respectively. Progressive disease (PD) occurred when a more than 25% increase in serum IgM level or progression of clinically significant disease parameters was observed.
groups
  1. description
    A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
    id
    OG000
    title
    Bortezomib, Dexamethasone, Rituximab
param Type
NUMBER
population Description
all enrolled patients
reporting Status
POSTED
time Frame
33.2 months
title
Response Rate
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice