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NCT00619684 · OUTCOME

Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR)

Lenalidomide in Treating Patients With Progressive or Recurrent Multiple Myeloma After a Donor Stem Cell Transplant · Source last updated 2017-05-18

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 9 years

What was measured

CR: No Monoclonal Protein (MP) in the blood AND no serum/urine MP by Immunofixation (IF \< 0) AND \< 5% plasma cells in bone marrow aspirate. VGPR: More than 90% decrease of MP and urine M protein \< 100 mg/d OR serum protein electrophoresis (SPEP)/urine protein electrophoresis(UPEP) negative but serum immunofixation (IFs) or IFu urine immunofixation (IFu) ) still positive. PR: Over 50% decrease of serum MP AND \> 90% reduction in 24h urinary light chain excretion or M proteinuria \< 200mg/d MR: Between 25 and 49% decrease of MP in the blood AND 50-89% reduction in 24h urinary light chain excretion (monoclonal proteinuria\>200 mg/d)

Groups in this outcome

Treatment (Lenalidomide)

Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity. lenalidomide: Given PO

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)18

Reported measurements

Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Lenalidomide)5Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VGPR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Lenalidomide)2Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Lenalidomide)3Not reportedNot reportedNot reportedNot reported
Minimal Response (MR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Lenalidomide)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Very Good Partial Response (VGPR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Partial Response (PR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Minimal Response (MR)
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
CR: No Monoclonal Protein (MP) in the blood AND no serum/urine MP by Immunofixation (IF \< 0) AND \< 5% plasma cells in bone marrow aspirate. VGPR: More than 90% decrease of MP and urine M protein \< 100 mg/d OR serum protein electrophoresis (SPEP)/urine protein electrophoresis(UPEP) negative but serum immunofixation (IFs) or IFu urine immunofixation (IFu) ) still positive. PR: Over 50% decrease of serum MP AND \> 90% reduction in 24h urinary light chain excretion or M proteinuria \< 200mg/d MR: Between 25 and 49% decrease of MP in the blood AND 50-89% reduction in 24h urinary light chain excretion (monoclonal proteinuria\>200 mg/d)
groups
  1. description
    Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity. lenalidomide: Given PO
    id
    OG000
    title
    Treatment (Lenalidomide)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 9 years
title
Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice