Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00477750 · OUTCOME

Patients With Overall Confirmed Response

Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2019-10-11

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
Every cycle during treatment

What was measured

Response that was confirmed on 2 consecutive evaluations.\> * Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and \<=5% plasma cells in bone marrow\> * Very Good Partial Response (VGPR): \>=90% reduction in serum M-spike, Urine M-spike \<100mg per 24 hours\> * Partial Response (PR): \>=50% reduction in serum M-spike, Urine M-spike \>=90% reduction or \< 200mg per 24 hours, or \>=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells

Groups in this outcome

Treatment (Lenalidomide, Melphalan, Prednisone)

Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression\> \> Intervention: Drug: melphalan 5mg/m\^2 orally days 1-4 every 28 days until progression\> \> Intervention: Drug: prednisone 60mg/m\^2, orally days 1-4 every 28 days 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
Treatment (Lenalidomide, Melphalan, Prednisone)26

Reported measurements

CR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Lenalidomide, Melphalan, Prednisone)3Not reportedNot reportedNot reportedNot reported
VGPR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Lenalidomide, Melphalan, Prednisone)5Not reportedNot reportedNot reportedNot reported
PR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Lenalidomide, Melphalan, Prednisone)10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    VGPR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    PR
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
Response that was confirmed on 2 consecutive evaluations.\> * Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and \<=5% plasma cells in bone marrow\> * Very Good Partial Response (VGPR): \>=90% reduction in serum M-spike, Urine M-spike \<100mg per 24 hours\> * Partial Response (PR): \>=50% reduction in serum M-spike, Urine M-spike \>=90% reduction or \< 200mg per 24 hours, or \>=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells
groups
  1. description
    Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression\> \> Intervention: Drug: melphalan 5mg/m\^2 orally days 1-4 every 28 days until progression\> \> Intervention: Drug: prednisone 60mg/m\^2, orally days 1-4 every 28 days until progression
    id
    OG000
    title
    Treatment (Lenalidomide, Melphalan, Prednisone)
param Type
NUMBER
reporting Status
POSTED
time Frame
Every cycle during treatment
title
Patients With Overall Confirmed Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice