A Phase II Study Evaluating the Efficacy/Safety of Lenalidomide With or Without Epoetin Beta in Transfusion-dependent ESA-resistant Patients With IPSS Low- and Intermediate-1 Risk Myelodysplastic Syndromes Without Chromosome 5 Abnormality.
This is a multi-center, open-label, randomized, Phase II study.
Patients will be treated either with arm A or B
- Arm A: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses.
- Arm B: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses combined with
weekly subcutaneous injections of Epoetin beta (60,000 Units/w).
Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.
Maintenance: responders will continue to follow the corresponding treatment arm until
relapse occurs; non responders at Evaluation of response at the end of 4 months according to
IWG 2006 and IWG 2000 criteria.
in arm A will be considered in failure of treatment and the introduction of Epoetin beta is
at the discretion of the physician.
The patients will be followed every 3 months for 12 months
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparing the efficacy of Lenalidomide alone to Lenalidomide with Epoetin beta in transfusion-dependent ESA-resistant
Primary outcome is a complete or partial response defined by the IWG 2006 criteria observed after 4 months of treatment. Comparison in the rate of response between the two groups will be performed with Chi-square test or if necessary Fisher exact test. Same analyzes will be performed with the IWG 2000 response definition .
After 4 months of treatment
Andréa TOMA, MD
Groupe Francophone des Myelodysplasies
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)