NCT00056160
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
PHASE3
COMPLETED
NCT00056160
INTERVENTIONAL
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
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
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.
Multiple Myeloma
- TREATMENT
-
- Type: DRUG
- Name: CC-5013
- Description: Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide 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.
- Arm Group Labels: CC-5013/Dex
-
- Type: DRUG
- Name: Dexamethasone
- Description: Subjects in the CC-5013/Dex and Placebo/Dex 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.
- Arm Group Labels: CC-5013/Dex, Placebo/Dex
- Celgene