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NCT00772915 · OUTCOME

Confirmed Response Rate

Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2020-01-18

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 18 cycles from registration

What was measured

Confirmed response rate is defined as the percentage of participants who achieved a response that was confirmed on 2 consecutive evaluations during treatment * Complete Response(CR): Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100 mg per 24 hours; \<=5% plasma cells in BM * Partial Response PR): \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels

Groups in this outcome

Lenalidomide With On-Demand Dexamethasone

Lenalidomide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, \& 22) orally with food until progression.

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 With On-Demand Dexamethasone38

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide With On-Demand Dexamethasone61Not reported4376Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43
        upper Limit
        76
        value
        61
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
description
Confirmed response rate is defined as the percentage of participants who achieved a response that was confirmed on 2 consecutive evaluations during treatment * Complete Response(CR): Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100 mg per 24 hours; \<=5% plasma cells in BM * Partial Response PR): \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels
dispersion Type
95% Confidence Interval
groups
  1. description
    Lenalidomide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, \& 22) orally with food until progression.
    id
    OG000
    title
    Lenalidomide With On-Demand Dexamethasone
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 18 cycles from registration
title
Confirmed Response Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice