Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes

Exclusion Criteria

• •Pregnant and lactating women and WCBP who are not using adequate contraception.
• •Myelosclerosis (or myelofibrosis) occupying \>30% of marrow space
• •Patients with iron deficiency (e.g., absent bone marrow iron store). If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be 220% and serum femtin not less than 50 ng/mL.
• •Patients with uncorrected Bl2 or folate deficiency.
• •Patients with contributing causes of anemia such as autoimmune or heredity, hemolytic disorders, or GI blood loss.
• •Patients with a history of malignancy, except basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
• •Patients with clinically significant, symptomatic and unstable pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary system diseases unrelated to their underlying hematologic disorder.
• •Life-threatening or active infection requiring parenteral antibiotic therapy or other serious concurrent illness.
• •Patients who have a history of testing positive for Hepatitis B surface antigenemia,'Hepatitis C, or HIV.
• •Inadequate organ hction: renal insufficiency \[serum creatinine levels \>1.5 x upper limit of normal (ULN)\] or hepatic impairment (bilirubin 22 mg/dL or AST/ALT 22 x ULN).
• •Patients may not have received another investigational study drug within 30 days of entry in the present study.
• •Requirement for ongoing therapy with corticosteroids.