Conditions: Myelodysplastic Syndromes Anemia
Keywords: MDS Myelodysplastic syndromes Anemia Epoetin alfa EPO
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate that Epoetin alfa treatment reduces red blood cell transfusions in anemic patients with myelodysplastic syndromes (MDS). Myelodysplastic syndromes are a group of disorders characterized by progressive bone marrow failure and an increased risk of development of leukemia.

Detailed description:
This is a randomized (patients are assigned by chance to a treatment group), double-blind (neither the patient or the physician know which treatment is being received by the patient), placebo-controlled, multicenter study of epoetin alfa in anemic patients who are diagnosed with myelodysplastic syndromes (MDS) according to protocol-specified criteria. Patients meeting entry criteria for the study will be randomly assigned to receive epoetin alfa 40,000 IU or 80,000 IU or a matching volume of placebo administered by subcutaneous (under the skin) injection once every week. Doses of study drug will be withheld, decreased, or increased on the basis of weekly hemoglobin concentrations monitored in patients and predefined dose adjustment guidelines. An Independent Data Monitoring Committee (IDMC) will periodically review study data and for the assessment of disease progression, an independent central reviewer will review bone marrow specimens and peripheral blood counts. Safety will be monitored throughout the study at predetermined intervals and as clinically indicated by physical examination, laboratory tests and evaluation of adverse events. Patients in the Treatment Phase will be randomly assigned to receive once weekly epoetin alfa subcutaneously (SC) at a dose of 40,000 IU (1 mL) or 80,000 IU (2ML) or matching volume of placebo (1 mL or 2 mL) once every week for 48 weeks. Patients may continue to receive double-blinded treatment after 48-weeks.

Arms:
arm 1: Epoetin alfa 40 000 IU subcutaneously once every week (1 mL dose) for 48 weeks arm 2: Epoetin alfa 80 000 IU subcutaneously once every week (2 mL dose) for 48 weeks arm 3: Placebo Matching volume 1 mL for 48 weeks arm 4: Placebo Matching volume 2 mLfor 48 weeks

Interventions: intervention 1: Placebo intervention 2: Epoetin alfa intervention 3: Placebo intervention 4: Epoetin alfa
Intervention descriptions: intervention 1: Matching volume 2 mLfor 48 weeks intervention 2: 40,000 IU subcutaneously once every week (1 mL dose) for 48 weeks intervention 3: Matching volume 1 mL for 48 weeks intervention 4: 80,000 IU subcutaneously once every week (2 mL dose) for 48 weeks

Protocol document: