Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .

• Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration.
• Baseline mean hemoglobin < 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline.
• More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion.
• Women must not be pregnant or lactating
• No use of another experimental study drug within 30 dy\ays of baseline
• Understand and sign written informed consent
• Able to adhere to study visit schedule, understand and comply with other protocol requirements.