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Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.

NCT01718379 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2016-11-08

No results posted yet for this study

Summary

The goal of the present study is to assess, through a randomized phase II trial, the efficacy and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent, ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5 abnormality.

Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4 months. Responders will be eligible for maintenance treatment with cycles identical to the first cycles, until relapse occurs or until unacceptable toxicity.

Conditions

Interventions

DRUG

Lenalidomide

Lenalidomide:10 mg per day during 21 days

DRUG

Epoetin beta

Epoetin beta: 60,000 Units/week.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Groupe Francophone des Myelodysplasies

    lead OTHER

Principal Investigators

  • Andréa TOMA, MD · Groupe Francophone des Myelodysplasies

  • François Dreyfus, MD · Groupe Francophone des Myelodysplasies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-11-30
Completion
2016-06-30

Countries

  • France
  • Monaco

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 NCT01718379 on ClinicalTrials.gov