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.

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT02612779

Run by

Bristol-Myers Squibb

People needed

74

Starts

2016-02-09

Expected to finish

2020-06-12

Last updated by the study team

2021-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Southern Cancer Center — Mobile, Alabama, United States
• Sansum Clinic - USOR — Santa Barbara, California, United States
• Colorado Blood Cancer Institute - PPDS — Denver, Colorado, United States
• Rocky Mountain Cancer Centers (Williams) - USOR — Denver, Colorado, United States
• Florida Cancer Specialists - EAST - SCRI - PPDS — St. Petersburg, Florida, United States
• Florida Cancer Specialists - NORTH - SCRI - PPDS — St. Petersburg, Florida, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• American Oncology Partners of Maryland, PA — Bethesda, Maryland, United States
• Bay Hematology Oncology — Easton, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Center — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Mount Sinai Medical Center — New York, New York, United States
• Greenville Health System — Greenville, South Carolina, United States
• Avera Health Care — Sioux Falls, South Dakota, United States
• Jones Clinic PC — Germantown, Tennessee, United States
• Tennessee Oncology NASH - SCRI - PPDS — Nashville, Tennessee, United States
• Texas Oncology (Loop) - USOR — San Antonio, Texas, United States
• Virginia Cancer Specialists (Leesburg) - USOR — Leesburg, Virginia, United States
• Swedish Medical Center — Seattle, Washington, United States
• Cancer Care Northwest — Spokane Valley, Washington, United States
• Aurora Health Care — Burlington, Wisconsin, United States

Full record on ClinicalTrials.gov

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