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NCT00114101 · OUTCOME

Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100

Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant · Source last updated 2026-08-26

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
Day 100

What was measured

Response was defined according to International Myeloma Working Group criteria (2006) * Complete Response: Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Partial Response: \>= 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 * Marginal Response: 25-49% reduction in serum M-component \& urine M-component by 50-89% which still exceeds 200mg/24hour * Progressive Disease: Defined in primary outcome measure * Stable Disease: Not meeting any of the criteria above

Groups in this outcome

Lenalidomide Maintenance

Beginning between day 100-110, patients receive oral lenalidomide once daily.

Placebo Maintenance

Beginning between day 100-110, patients receive oral placebo once daily. (closed as of 12/17/09)

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 Maintenance231
Placebo Maintenance229

Reported measurements

Complete response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Maintenance67Not reportedNot reportedNot reportedNot reported
Placebo Maintenance79Not reportedNot reportedNot reportedNot reported
Partial response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Maintenance115Not reportedNot reportedNot reportedNot reported
Placebo Maintenance109Not reportedNot reportedNot reportedNot reported
Marginal response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Maintenance11Not reportedNot reportedNot reportedNot reported
Placebo Maintenance5Not reportedNot reportedNot reportedNot reported
Stable disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Maintenance38Not reportedNot reportedNot reportedNot reported
Placebo Maintenance32Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Maintenance0Not reportedNot reportedNot reportedNot reported
Placebo Maintenance3Not reportedNot reportedNot reportedNot reported
Unknown
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Maintenance0Not reportedNot reportedNot reportedNot reported
Placebo Maintenance1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        79
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        115
      2. group Id
        OG001
        value
        109
    title
    Partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        5
    title
    Marginal response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        32
    title
    Stable disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
    title
    Progressive disease
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Unknown
denoms
  1. counts
    1. group Id
      OG000
      value
      231
    2. group Id
      OG001
      value
      229
    units
    Participants
description
Response was defined according to International Myeloma Working Group criteria (2006) * Complete Response: Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Partial Response: \>= 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 * Marginal Response: 25-49% reduction in serum M-component \& urine M-component by 50-89% which still exceeds 200mg/24hour * Progressive Disease: Defined in primary outcome measure * Stable Disease: Not meeting any of the criteria above
groups
  1. description
    Beginning between day 100-110, patients receive oral lenalidomide once daily.
    id
    OG000
    title
    Lenalidomide Maintenance
  2. description
    Beginning between day 100-110, patients receive oral placebo once daily. (closed as of 12/17/09)
    id
    OG001
    title
    Placebo Maintenance
param Type
NUMBER
reporting Status
POSTED
time Frame
Day 100
title
Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice