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Brief Title: Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 and Anti-TIGIT
Official Title: A Phase I/II Assessment of Combination Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 (BMS-986016) and Anti-TIGIT (BMS-986207)
Study ID: NCT04150965
Brief Summary: This a Phase I/II randomized trial for patients with relapsed refractory Multiple Myeloma who have relapsed after treatment with prior therapies. The protocol is designed to evaluate two agents, Anti-LAG-3 and Anti-TIGIT, in order to understand their immunologic effects and safety both as single agents and in combination with pomalidomide and dexamethasone. In these arms, patients will be treated with either Anti-LAG-3 or Anti-TIGIT respectively for one cycle as single agent followed by the addition of pomalidomide and dexamethasone in combination for subsequent cycles. A third arm allows patients to be treated with the FDA approved combination of elotuzumab plus pomalidomide and dexamethsone as a control. This arm will thus allow a concurrent standard of care comparator for the experimental arms.
Detailed Description: This study will enroll 104 patients to one of three treatment arms. The study is open to patients relapsing with refractory Multiple Myeloma who have: * received 3 prior lines of therapy * exposed to each of these 3 drug classes: * IMiD * proteasome inhibitors, and * anti-CD38 monoclonal antibody * relapsed and refractory are defined using the IMWG criteria: * disease that is non-responsive while on salvage therapy or progresses within 60 days of last therapy in patients who have achieved minimal response or better at some point previously to then progressing in their disease course.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Emory University, Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Washington University School of Medicine Division of Medical Oncology, Saint Louis, Missouri, United States
Hackensack Meridian Medical Center, Hackensack, New Jersey, United States
Mount Sinai School of Medicine, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Name: Madhav V. Dhodapkar, M.D.
Affiliation: Medical Monitor
Role: PRINCIPAL_INVESTIGATOR
Name: Hearn J. Cho, M.D., Ph.D.
Affiliation: Chief Medical Officer
Role: PRINCIPAL_INVESTIGATOR
Name: Daniel Auclair, Ph.D.
Affiliation: Chief Scientific Officer
Role: PRINCIPAL_INVESTIGATOR