Multiple Myeloma Clinical Trial

A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.

Summary

Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients.

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Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.
ECOG Performance Status less than or equal to 2
Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, has not been treated). If re-enrolled, the subject must be re-consented.

EPd Cohort:

must have received at least 1 but no greater than 2 prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy)
Subjects must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles (full therapeutic dose) and must have been deemed as relapsed, refractory, or intolerant. Refractory is defined as progressing on-treatment or within 60 days of the last dose.

EN Cohort:

Subjects must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent OR were double-refractory to both an IMID and a PI. Refractory is defined as progressing on-treatment or within 60 days of the last dose.

Exclusion Criteria:

Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Subjects with Central Nervous System involvement with multiple myeloma

Other protocol defined inclusion/exclusion criteria could apply.

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

74

Study ID:

NCT02612779

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 20 Locations for this study

See Locations Near You

Southern Cancer Center
Mobile Alabama, 36607, United States
Sansum Clinic - USOR
Santa Barbara California, 93105, United States
Colorado Blood Cancer Institute - PPDS
Denver Colorado, 80218, United States
Rocky Mountain Cancer Centers (Williams) - USOR
Denver Colorado, 80218, United States
Florida Cancer Specialists - EAST - SCRI - PPDS
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Saint Petersburg Florida, 33705, United States
Illinois Cancer Care
Peoria Illinois, 61615, United States
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States
Bay Hematology Oncology
Easton Maryland, 21601, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Center
Detroit Michigan, 48201, United States
Washington University
Saint Louis Missouri, 63110, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Greenville Health System
Greenville South Carolina, 29615, United States
Avera Health Care
Sioux Falls South Dakota, 57105, United States
Jones Clinic PC
Germantown Tennessee, 38138, United States
Tennessee Oncology NASH - SCRI - PPDS
Nashville Tennessee, 37203, United States
Texas Oncology (Loop) - USOR
San Antonio Texas, 78217, United States
Virginia Cancer Specialists (Leesburg) - USOR
Leesburg Virginia, 20176, United States
Swedish Medical Center
Seattle Washington, 98104, United States
Cancer Care Northwest
Spokane Valley Washington, 99216, United States
Aurora Health Care
Burlington Wisconsin, 53105, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

74

Study ID:

NCT02612779

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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