Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00478218 · OUTCOME

Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment

Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2011-08-31

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
Duration of Treatment (up to 5 years)

What was measured

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

LCD (Cyclophosphamide 300 mg/m^2)

Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22

LCD (Cyclophosphamide 300 mg)

Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22

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

Analysis denominator · Participants

GroupSource count
LCD (Cyclophosphamide 300 mg/m^2)34
LCD (Cyclophosphamide 300 mg)19

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LCD (Cyclophosphamide 300 mg/m^2)28Not reportedNot reportedNot reportedNot reported
LCD (Cyclophosphamide 300 mg)16Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        16
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      19
    units
    Participants
description
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
  1. description
    Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
    id
    OG000
    title
    LCD (Cyclophosphamide 300 mg/m^2)
  2. description
    Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
    id
    OG001
    title
    LCD (Cyclophosphamide 300 mg)
param Type
NUMBER
reporting Status
POSTED
time Frame
Duration of Treatment (up to 5 years)
title
Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice