Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

Exclusion Criteria

• •Pregnant or lactating females.
• •Prior therapy with lenalidomide.
• •An abnormality of chromosome 5 involving a deletion between bands q31 and q33.
• •Lab Abnormality: Absolute neutrophil count (ANC) \<500 cells/mm3 (0.5 x 109/L)
• •Lab Abnormality: Platelet count \<50,000/mm3 (50 x 109/L)
• •Lab Abnormality: Serum creatinine \>2.5 mg/dL (221 mmol/L)
• •Lab Abnormality: Serum glutamic oxaloacetic transaminase/Aspartate transaminase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) \>3.0 x upper limit of normal (ULN)
• •Lab Abnormality: Serum total bilirubin \>2.0 mg/dL (34 mmol/L)
• •Prior ≥ grade 3 National Cancer Institute (NCI) Common Toxicity Criteria (CTC) (Appendix VI) allergic reaction/hypersensitivity to thalidomide.
• •Prior ≥ grade 3 NCI CTC (Appendix VI) rash or any desquamation (blistering) while taking thalidomide.
• •Clinically significant anemia due to factors such as iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis or gastrointestinal bleeding
• •If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be \> 20 % and serum ferritin not less than 50 ng/mL.
• •Use of hematopoietic growth factors within 7 days of the first day of study drug treatment.
• •Chronic use (\>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to \>10 mg/day of prednisone) within 28 days of the first day of study drug treatment.
• •Use of experimental or standard drugs (i.e. chemotherapeutic, immunosuppressive, and cytoprotective agents) for the treatment of MDS within 28 days of the first day of study drug treatment.
• •Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for greater than or equal to 3 years.
• •Use of any other experimental therapy within 28 days of the first day of study drug treatment.