An international study is open comparing a triplet of isatuximab, pomalidomide, and dexamethasone to a doublet of pomalidomide and dexamethasone in refractory or relapsed and Refractory Multiple Myeloma Patients.
The study aims to see if the new monoclonal antibody isatuximab provides significant added benefit to a standard combination of an immunomodulator (pomalidomide) and a steroid (dex).
Isatuximab is a monoclonal antibody that targets CD38, a protein typically found on the surface of myeloma cells. Last year at the 2016 ASCO meeting, findings from a Phase II study for patients who were almost all double refractory showed that it had single-agent activity, or had impact on myeloma even when given alone. In the study, approximately 40 percent of patients were quadruple refractory and most patients had received a prior stem cell transplant.
“This progression-free survival for a single-agent in a heavily pretreated population is quite impressive; however, what I think is even more impressive is the overall survival data,” said Joshua Richter, a hematologist/oncologist specializing in multiple myeloma at the John Theurer Cancer Center. “The median duration of response ranged from 8.75 to 12.9 months. The median overall survival has not yet been reached for some of the cohorts. There is an impressive response rate in the classically higher-risk groups of elderly patients, poor renal function and high-risk cytogenetics.”
There are 8 active sites for this trial.
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