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

Inclusion Criteria:

- Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not
therapy related.

- Age ≥ 18 at the time of signing informed consent

- Patient must be able to adhere to the study visit schedule and other protocol
requirements.

- Patient must understand and voluntarily sign an informed consent document.

- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
test.

- Sexually active WCBP must agree to use adequate contraceptive methods (oral,
injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine
device; barrier contraceptive with spermicide; or vasectomized partner).

- Women must not be pregnant or lactating.

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.