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

This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of
the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse
high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple
myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups:
Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1
to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle;
Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each
28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily
on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy.
Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on
Days 1 to 4 for the remaining cycles.

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.