María-Victoria Mateos, MD, PhD, discusses the design of the ongoing phase 3 CANOVA trial in patients with relapsed/refractory t(11;14) multiple myeloma.
María-Victoria Mateos, MD, PhD, associate professor of medicine, and director of the Myeloma unit at the University of Salamanca in Spain, discusses the design of the ongoing phase 3 CANOVA trial in patients with relapsed/refractory t(11;14) multiple myeloma.
The ongoing multicenter, open-label study will randomize patients with relapsed/refractory t(11;14) multiple myeloma to venetoclax (Venclexta) plus dexamethasone or pomalidomide (Pomalidomide) plus dexamethasone (Pd). The primary end point of the study is progression-free survival, says Mateos. Key secondary end points include the rate of very good partial response or better, overall response rate, overall survival, duration of response, rate of minimal residual disease, pharmacokinetics of venetoclax, and safety.
The rationale for the trial stems from the fact that venetoclax is a highly selective and potent oral BCL-2 inhibitor that has shown promising activity alone or in combination with other agents in patients with t(11;14), and Pd is a standard option for patients who have been previously exposed to proteasome inhibitors and immunomodulatory drugs. The estimated enrollment is 244 patients, says Mateos. To be eligible for enrollment, patients had to have received at least 1 proteasome inhibitor and have disease that is refractory to lenalidomide (Revlimid).