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