CLINICAL TRIAL: Nivolumab, Elotuzumab, Pomalidomide & Dex for Relapsed/Refractory Myeloma
Checkpoint inhibitors are now entering clinical trials are being added to standard myeloma combinations. One such phase 3, randomized, multi-center trial by Bristol-Myers Squibb and AbbVie is will compare Nivolumab, pomalidomide, and dexamethasone to pomalidomide and dexamethasone in subjects with relapsed and refractory multiple myeloma. The study includes a third arm evaluating the clinical benefit and the safety of the quad combination therapy of elotuzumab, nivolumab, pomalidomide and dexamethasone in the same patient population. Subjects in the control arm are allowed to cross-over to the exploratory arm at the time of progression. Checkpoint inhibitors are a new type of immunotherapy that take the brakes off of the immune system. You can learn more about how this new class of drugs work in a recent show with Dr. Don Benson, MD, PhD, of Ohio State University on Myeloma Crowd Radio. This is one of the first trials to combine two types of immunotherapies (a checkpoint inhibitor AND a monoclonal antibody) with standard myeloma drugs. Approximately 406 patients will be enrolled in this study at multiple sites. Inclusion criteria includes...
- Refractory or relapsed and refractory multiple myeloma
- Measurable disease
- Have received ≥ 2 lines of prior therapy which must have included an immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination
- Solitary bone or extramedullary plasmacytoma disease only
- Active plasma cell leukemia