Darbepoetin Alpha in Myelodysplastic Syndromes (MDS)

Inclusion Criteria: * MDS of the following subtypes: * RA, RAS, RAEB with marrow blasts \< 10% (according to FAB), * RA, RARS, RCMD, RAEB 1, CMML 1 with ≤ 10% WBC counts \< 13000/mm3 (according to WHO classification) * Anemia, defined by Hb \< 10 g/dl or RBC transfusion requirement in the absence of other causes of anemia (especially renal failure, iron, or folate deficiency) * IPSS ≤ 1(ie IPSS low or intermediate 1) * EPO level \< 500 UI/L * Ability to perform physical tests of exercise tolerance * No renal failure (creatinine ≤ 120% normal upper value for the center) * No underlying severe condition * ECOG performance status score of 0, 1, or 2 * Must be 18 years of age or older at the time of screening * Written informed consent Exclusion Criteria: * Therapy related MDS * MDS with IPSS \> 1 (int 2 or high score) * Chronic myelomonocytic leukemia with \> 10% marrow blasts or WBC \> 13000/mm3 * Uncontrolled systemic hypertension * Cardiac condition: uncontrolled angina, congestive heart failure, or uncontrolled cardiac arrhythmia * Creatinine level \> 120% upper normal value for the center. * Clinically significant systemic infection or chronic inflammatory disease (eg, rheumatoid arthritis) present at the time of screening * Serum folate ≤ 2.0 ng/mL or vitamin B12 ≤ 200 pg/mL (anemia related to nutritional deficiencies) * Other causes of anemia (eg, hemolysis, bleeding, sickle cell anemia, renal disease) * Pregnant (ie, positive βhCG test) or breast feeding female subjects * Women of childbearing potential and not using adequate contraceptives * Known positive antibody response to an erythropoietic growth factor * Known hypersensitivity to darbepoetin alpha or any of its excipients, or to recombinant erythropoietins * Patient unable to understand the protocol or to be adequately followed up. * History of seizures * Previous history of thrombotic events * Concomitant treatment with thalidomide