A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)

Inclusion Criteria:- Diagnosis: Bone marrow aspirate/biopsy-proven MDS for > 2 months prior to enrollment. MDS French-American-British (FAB) subtypes refractory anemia (RA), RA with ringed sideroblasts (RARS), RA with excess blasts (RAEB), and non-proliferative chronic myelomonocytic leukemia (CMML) [WBC < 12,000/ml]. Patients must have an untransfused hemoglobin < 10.0 g/dL and/or patients must be red cell transfusion-dependent for a period of at least 2 months prior to study entry. - Laboratory: Bilirubin < or = to 2 mg/dL ALT/SGPT < or = to 2.5 x the upper limit of normal (ULN) Normal renal function (Stanford: serum creatinine < 1.2 mg/dL [male], < 1.0 mg/dL [female]; Vanderbilt: < 1.5 mg/dL). Age: > or = to 18 Other: ECOG performance status 0-2. Patients may receive standard supportive care, including transfusions and antibiotics as required. Patients must be r-HuEPO naive or must not have received prior treatment with r-HuEPO > or = to 40,000 U/week for more than 4 weeks. Exclusion Criteria:- Patients with secondary MDS or prior allogeneic bone marrow transplant.