A Phase 2, Randomized Study of Bortezomib/dexamethasone With or Without Elotuzumab in Subjects with Relapsed/ Refractory Multiple Myeloma (CA204009)

Service: Trial Number:
061-12
Principal Investigator: Conducted at:
Long Beach Memorial, Orange Coast Memorial, Saddleback Memorial - San Clemente
Currently enrolling additional patients:
Yes
Age Range:
18 years & up

MM is a cancer of the plasma cell (type of white blood cell), which is an important part of the immune system. Elotuzumab is a manufactured protein directed against a target found on MM cells. Elotuzumab was observed to kill myeloma cells in laboratory studies, and results of earlier clinical studies in patients with myeloma showed encouraging results when used in combination with Bd. It is currently unknown whether the combination of elotuzumab with standard therapy (i.e. regimen of Bd) is better than standard therapy alone. The purpose of this study is to determine if BdE (bortezomib, dexamethasone, and elotuzumab) is more effective in the treatment of relapsed or refractory MM compared with a standard treatment of Bd alone. This study will also assess the safety of BdE compared with Bd alone. This study will also measure how the body processes elotuzumab. A treatment cycle is defined as 21 days (3 weeks) for the first 8 cycles. Beginning with Cycle 9, a treatment cycle is defined as 28 days (4 weeks). It is not known how long participation in the study may last. Treatment will continue until disease gets worse, the subject experiences unacceptable side effects, or the subject or doctor decide it is best to withdraw from the study. Randomization takes place in a 1:1 ratio, so each subject has an equal chance of Bd:BdE. No placebo will be used in this study. The following study drugs will be given to subjects in both arms of the study: Bortesomib into the vein (IV) and Dexamethasone (by mouth or IV). If a subject is randomized to the experimental arm, they will receive Elotuzumab (IV) as well.

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