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NCT00142168 · OUTCOME

Major Response Rate

CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia · Source last updated 2016-04-21

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
34.3 months

What was measured

Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a \>50% reduction in serum IgM levels.

Analysis population: Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.

Groups in this outcome

Lenalidomide and Rituximab

Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.

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

Analysis denominator · Participants

GroupSource count
Lenalidomide and Rituximab12

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Rituximab4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a \>50% reduction in serum IgM levels.
groups
  1. description
    Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
    id
    OG000
    title
    Lenalidomide and Rituximab
param Type
NUMBER
population Description
Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.
reporting Status
POSTED
time Frame
34.3 months
title
Major Response Rate
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice