Trial Information

Summary: Double-Blinded Placebo Controlled Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients with Newly Diagnosed Multiple Myeloma.

The purpose of this study is to compare the effects (good and bad) of dexamethasone (a steroid and a commonly used therapy for multiple myeloma) with dexamethasone + CC-5013 (an investigational therapy for myeloma) on you and your disease to see which is better. CC-5013 is not approved by the FDA for the treatment of multiple myeloma.

CC-5013 is a drug that is related to thalidomide. In lab experiments using it against myeloma cells, CC-5013 is much stronger than thalidomide. In clinical studies involving about 60 people who had myeloma that did not respond to previous therapies (including thalidomide in many cases), CC-5013 by itself was effective in about 1/3 of the patients. The response rate in other clinical trials seen in patients treated with CC-5013 at the doses used in this study seemed to have been somewhat higher, with about three-quarters of patients improving.

Primary Endpoint:

To compare myeloma progression-free survival between patients treated with dexamethasone+CC-5013 as compared to patients treated with dexamethasone + placebo.

Secondary Endpoints:

• Compare overall response rates in each arm.
• Compare major response rate (>75% decrease in M-protein) in each arm.
• Compare time to best response in each arm.
• Compare overall survival in each arm.
• Compare toxicity profile of two arms, including thrombotic complications.
• investigate biological endpoints including effects on gene expression and ultimately proteomic analysis.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.