Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.

Inclusion Criteria: * Age ³ 18 years * Low or intermediate-1 risk MDS according to IPSS, and FAB classification of RA, RARS, or RAEB with blasts £ 10% * Predictive variables of good response (serum erythropoietin levels \< 500 IU/l and transfusion requirements \< 2 packed RBC/month over the preceding 2 months) * Anaemia (Hb £ 10 g/dL), confirmed in the 14 days before day 1 of the study * Life expectancy of at least 6 months * ECOG Performance status score of 0, 1, or 2 * Subject must sign and date the Informed Consent (approved by a Clinical Research Ethics Committee - CREC), before any study-specific procedure is performed Exclusion Criteria: * Known history of convulsive disorders * Poorly controlled hypertension (diastolic blood pressure \> 100 mmHg) at screening * Inadequate liver function (total bilirubin \> two times the upper limit of the normal range (ULN), and liver enzymes (ALT, AST) \> two times ULN) * Inadequate renal function (serum creatinine concentration \> 2 mg/dL) * Ferritin \< 100 ng/ml or transferrin saturation index (TSI) \< 16%; Vitamin B12 deficiency (\< 200 pg/ml) or folate deficiency (\< 2 ng/ml) * Clinically-relevant haemorrhages * Haemolytic anaemia * Cardiac condition: uncontrolled angina, congestive heart failure, or uncontrolled cardiac arrhythmia * Clinically significant systemic infection or chronic inflammatory disease present at time of screening * Any concomitant therapy used to treat MDS (including other growth factors than those described as part of this protocol, chemotherapy, antibody-based cancer treatment, hormonal therapy, interferon, and interleukins) * Treatment with rHuEPO or darbepoetin alfa over the 4 weeks prior to Day 1 of the study * More than 2 RBC transfusions over the 28 days prior to Day 1 of the study * Pregnant or breast feeding women * Subjects of childbearing-potential who do not take adequate contraceptive measures, in the opinion of the investigator * Known hypersensitivity to any mammal-derived recombinant product