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Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality

NCT00179621 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2011-04-14

Study results available
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Summary

The purpose of this study was to compare 2 doses (10 mg and 5 mg) of lenalidomide to that of placebo in subjects with red blood cell (RBC) transfusion-dependent low- or intermediate-1-risk IPSS MDS associated with a deletion (del) 5q\[31\] cytogenetic abnormality. Study participants were randomized to one of the two treatment groups or to placebo and took the study drug for 16 weeks. At this timepoint, participants were evaluated for erythroid response. If participants did not achieve at least a minor erythroid response, they were discontinued from the Double-Blind phase and entered into the Open-Label phase. All erythroid responders at Week 16 were to continue in the Double-Blind phase for up to 52 weeks. For participants that were still responding at the end of Double-Blind phase, they could then rollover into the Open-Label phase for an additional two years. Participants could remain on study for up to a total of 3 years. All participants who discontinued from the study were followed every 4 months for overall survival and progression to acute myeloid leukemia (AML).

Conditions

Interventions

DRUG

Lenalidomide 5 mg

Lenalidomide 5 mg daily 28/28 days

DRUG

Lenalidomide 10 mg

Lenalidomide 10 mg daily 21/28 days

DRUG

Placebo

Placebo, matching to active study drug arms

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Celgene Corporation

    lead INDUSTRY

Principal Investigators

  • Jay Backstrom, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2008-06-30
Completion
2010-06-30

Countries

  • Belgium
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00179621 on ClinicalTrials.gov