SWOG 0232: "Double-Blinded Placebo Controlled Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients with Newly Diagnosed Multiple Myeloma"
Sponsor:
Southwest Oncology Group
PI:
Laura Hutchins, M.D.
Phase:
III
Purpose:
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.
Eligibility:
An estimated 5 patients, ages 18 and older, will be entered onto this study at this institution. Overall accrual is anticipated to be 500 patients.
Treatment:
You will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. It is like flipping a coin. A computer determines which group you are put in. Neither you nor the researcher will know or choose what group you will be in. You will have a 50/50 chance of being placed in either group. Half of participants will be treated first with the combination of dexamethasone tablets and CC-5013 capsules. The other group of participants will be treated with dexamethasone alone, and will also receive a placebo capsule (a capsule with no active ingredients that looks identical to the CC-5013 capsules).
