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NCT00567229 · OUTCOME

Final Response Rate After 4 Courses of Treatment

Lenalidomide and Rituximab in Treating Patients With Recurrent and/or Refractory Multiple Myeloma · Source last updated 2015-11-20

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
2 years

Groups in this outcome

Lenalidomide and Rituximab

This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.

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 Rituximab3

Reported measurements

Stable Disease (SD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Rituximab2Not reportedNot reportedNot reportedNot reported
Progression of Disease (POD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Rituximab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Stable Disease (SD)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Progression of Disease (POD)
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
groups
  1. description
    This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
    id
    OG000
    title
    Lenalidomide and Rituximab
param Type
NUMBER
reporting Status
POSTED
time Frame
2 years
title
Final Response Rate After 4 Courses of Treatment
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice