Condition: Multiple Myeloma · Sponsor: Oncotherapeutics
Despite the recent introduction of novel anti-multiple myeloma (MM) agents, high risk MM remains with poor prognosis and a therapeutic challenge. Elotuzumab (ELO) is a humanized monoclonal antibody that recognizes CS1/CD139, a molecule highly expressed in MM cells. The ELO (10 mg/kg), lenalidomide (LEN) and dexamethasone (DEX) combination achieves high overall response rates (ORR) and long progression-free survival (PFS) for patients with relapsed/refractory disease (RR) MM and those with impaired renal function. However, its efficacy for MM patients with high risk characteristics is still unknown. Pomalidomide (POM) is a recently approved immunomodulatory agent (IMiD) that produces response rates for high-risk RRMM patients when used in combination with DEX and other agents, including the proteasome inhibitor (PI) bortezomib (BTZ). POM has also demonstrated activity for LEN refractory patients. Carfilzomib (CFZ) is a potent second generation PI that has shown to be efficacious for IMiD and BTZ refractory patients as well as high risk patients carrying cytogenetic abnormalities. In this study, we propose to evaluate efficacy and safety of ELO in combination with POM, DEX and CFZ for high-risk RRMM patients.
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| California Cancer Associates for Research & Excellence (cCARE) | Encinitas, California, United States | — |
| Robert A. Moss, MD, FACP, Inc | Fountain Valley, California, United States | — |
| Pacific Cancer Care | Monterey, California, United States | — |
| James Berenson, MD, Inc | West Hollywood, California, United States | — |
| Millennium Oncology Research Clinic | Pembroke Pines, Florida, United States | — |
| Regional Cancer Care Associates MD LLC | Bethesda, Maryland, United States | — |
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Source record: clinicaltrials.gov/study/NCT03104270