A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma (CA204006)

Trial Purpose and Description

Trial Purpose

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

Primary Outcome Measures:

·      Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment. [ Time Frame: Every 4 weeks (-1/+3 days) relative to the first dose of study medication. ]

Secondary Outcome Measures:

·      Objective Response Rate - The percentage of patients who have a partial or complete response to study therapy. [ Time Frame: All response endpoints assessed every 4 weeks (-1/+3 days). ]

Overall Survival- The period of time from study entry until the date of death or last known date alive. [Time Frame: Survival will be assess every 16 weeks in the Follow Up Phase of the trial]

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