A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

Inclusion Criteria:

- Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.

- No more than 3 previous anti-myeloma regimens

- No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg)
within 6 months of study randomization.

- Measurable levels of myeloma paraprotein in serum or urine (24-hour collection
sample).

Exclusion Criteria:

- Prior development of disease progression during high-dose dexamethasone containing
therapy.

- Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed

- Laboratory abnormalities: Platelet count less than 75,000/mm cubed

- Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL

- Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate
transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine
transaminase [ALT])greater than 3.0 x upper limit of normal

- Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL

- Prior history of malignancies other than multiple myeloma unless the subject has been
free of the disease for greater than or equal to 5 years.

- Known hypersensitivity to thalidomide or dexamethasone.

- Development of a desquamating rash while taking thalidomide.