A Study Evaluating Epoetin Alfa 40,000 IU (International Units) Every Week or 80,000 IU Every Week Compared to Placebo in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes at Risk for Transfusion

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Centocor Ortho Biotech Services, L.L.C.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Diagnosis of MDS according to protocol-specified criteria via bone marrow studies performed within 12 weeks before randomization

Exclusion Criteria:

• No prior or concurrent treatment with epoetin alfa or any other approved or experimental erythropoietin stimulating agents (ESAs) within the previous 12 months before randomization

• No prior use of approved or experimental agents for the treatment of MDS or recent treatment with granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) for the treatment of neutropenia

• Patients must not have secondary MDS or anemia caused by factors other than MDS (including iron deficiency, vitamin B12 or folate deficiencies, hemolysis, chronic renal failure, or gastrointestinal bleeding)

• No history (within 12 months) of deep venous thrombosis

• or history (within 6 months) of stroke, acute coronary syndrome or other arterial thrombosis

• Not currently receiving therapeutic anticoagulants or have uncontrolled hypertension

• No uncontrolled disease or dysfunction deemed clinically significant by the Investigator not attributable to MDS