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NCT00060346 · OUTCOME

Objective Response to Treatment

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia · Source last updated 2023-06-29

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
90% Confidence Interval
Time frame
Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry

What was measured

Objective response assessed using standard myeloma response criteria. Objective response is defined as a \> 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.

Analysis population: All eligible and treated patients are included in this analysis.

Groups in this outcome

Rituximab + CHOP

Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by: Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 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
Rituximab + CHOP16

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Rituximab + CHOP0.938Not reported0.7360.997Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.736
        upper Limit
        0.997
        value
        0.938
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Objective response assessed using standard myeloma response criteria. Objective response is defined as a \> 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.
dispersion Type
90% Confidence Interval
groups
  1. description
    Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by: Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily
    id
    OG000
    title
    Rituximab + CHOP
param Type
NUMBER
population Description
All eligible and treated patients are included in this analysis.
reporting Status
POSTED
time Frame
Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry
title
Objective Response to Treatment
type
PRIMARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice