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.