Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome (MDS)

Objective of the trial Assess the level of haematological response according to IWG 2000 and IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment;

To evaluate the predictive value of the rate of reticulocytes at Day 8 on the erythroid response;

• Assess time to response
• Assess tolerance
• Assess the impact on quality of life using the FACT-An and EQ-5D measurement scales;
• Assess functional capacity:

Cardiovascular performance on effort by the 6-minute walk test Performing the " Short Physical Performance Battery " tests

Evaluation The evaluation of response according to the IWG 2000 and IWG 2006 criteria will be held at 12 and 24 weeks of treatment

Inclusion criteria

• Written informed consent
• Must be 18 years of age or older at the time of screening
• Myelodysplastic Syndrome of the following subtypes : RA, RAS, RCMD, RCMD-RS, RAEB 1, with IPSS score low or intermediate 1 (IPSS score < 1 ) and with anemia defined by Hb < 10 g/dl (with RBC transfusion requirement or not)
• For women of childbearing potential, need for effective contraception throughout the study period.

Exclusion criteria

• Intensive Chemotherapy within 3 months before inclusion
• Myelodysplastic Syndrome with IPSS score >1
• Treatment with rHu-Epo or rHu-GCSF within 2 months before inclusion
• EGOG > 3 ;
• Other causes of anemia (eg. , Iron deficiency, vitamin B12 or folic acid, hypothyroidism before correction)
• Uncontrolled arterial hypertension
• Life expectancy less than 6 months
• CMML
• Pregnant or breast feeding female subjects
• Patients with creatinine clearance less than 30ml/min.