Phase III Lenalidomide/Dexamethasone +/- Elotuzumab Previously Untreated Multiple Myeloma

Trial Purpose and Description

Trial Purpose

This is a study that looks at what happens when we add elotuzumab to treatment with lenalidomide and dexamethasone on previously untreated multiple myeloma. If you agree to take part in this study you will take lenalidomide and dexamethasone either with or without elotuzumab. Elotuzumab is a manufactured protein directed against a target found on multiple myeloma 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 lenalidomide and dexamethasone. It is currently unknown whether the combination of elotuzumab with standard therapy is better than standard therapy alone. Lenalidomide is a drug that changes the immune system and it may also get in the way of the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide in combination with dexamethasone is approved by the United States by the FDA for the treatment of patients with multiple myeloma who have received at least 1 prior multiple myeloma therapy. Dexamethasone is a steroid that is commonly used, either alone or in combination with other drugs, to treat multiple myeloma. While the combination of lenalidomide and dexamethasone has not been approved by regulatory authorities for the treatment of newly diagnosed myeloma, it is commonly used, and your physician believes that this is an appropriate choice for treatment of your myeloma at this time. The purpose of this study is to determine if: •Elotuzumab ( the study drug) given with lenalidomide and dexamethasone is more effective in the initial treatment of multiple myeloma compared with a standard treatment of lenalidomide and dexamethasone alone. •This study will also assess the safety of elotuzumab given with lenalidomide and dexamethasone compared with lenalidomide and dexamethasone alone. •This study will also measure how your body processes elotuzumab.

Participation Guidelines

Eligibility Criteria

Inclusion Criteria:

·                     Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:

o  have not received any prior systemic anti-myeloma therapy AND

o  have measurable disease AND

o  are not candidates for high-dose therapy plus stem-cell transplantation because of age (≥ 65 years) or coexisting conditions

Exclusion Criteria:

·                     Subjects with non-secretory or oligo-secretory or free light-chain only myeloma

·                     Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions

·                     Monoclonal Gammopathy of Undetermined Significance (MGUS)

·                     Active plasma cell leukemia

·                     Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)

Sponsor:

Bristol-Myers Squibb

Dates:

11/18/2011

Last Updated:

Study HIC#:

1108008911

Clinicaltrials.gov ID: Yale2322918