Combination Study for High Risk Multiple Myeloma Patients
Status:
Active, not recruiting
Trial end date:
2020-10-01
Target enrollment:
Participant gender:
Summary
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.