A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.

To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."

Inclusion Criteria:

• Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.
• Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1, or 2
• Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug

Exclusion Criteria:

• Prior development of disease progression during high-dose dexamethasone containing therapy
• Pregnant or lactating females
• The development of a desquamating rash while taking thalidomide
• Use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
• Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm3
• Laboratory abnormalities: Platelet count < 75,000/mm3
• Laboratory abnormalities: Serum creatinine > 2.5 mg/dL
• Laboratory abnormalities: Serum Serum glutamic oxaloacetic transaminase (SGOT)/Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine aminotransferase (ALT) > 3.0 x upper limit of normal
• Laboratory abnormalities: Serum total bilirubin > 2.0 mg/dL
• Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for ≥ 3 years.