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
- 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