Combination Therapy With Selinexor, Lenalidomide, and Dexamethasone in Resistant Myeloma
Posted: Monday, October 14, 2019
A phase III trial has shown that an oral combination of selinexor, lenalidomide, and dexamethasone produced significant activity in patients with relapsed or refractory multiple myeloma who have not previously received lenalidomide. Darrell White, MD, of Dalhousie University in Nova Scotia, presented his team’s findings at the 2019 International Myeloma Worship (IMW) in Boston (Abstract OAB-083).
The STOMP trial recruited 24 patients with relapsed or refractory multiple myeloma who had received one or more prior therapies. Selinexor was dose escalated in two different regimens: either alone once weekly at 80 mg or at 60 mg once or twice weekly in combination with lenalidomide and dexamethasone.
The median age of enrolled patients was 67, and 54% of patients were men. Dose-limiting toxicities in the first phase of the trial included grade 3 anorexia and weight loss, grade 4 thrombocytopenia, and grade 3 fatigue in the 60-mg selinexor twice-weekly group. There was also grade 4 thrombocytopenia reported in with 80 mg of selinexor. The group receiving selinexor once weekly at 60 mg reported no dos- limiting toxicities, so the recommended phase II dose was 60 mg weekly, 25 mg of lenalidomide daily, and 4 mg of dexamethasone weekly.
A total of 20 patients were evaluable for response. For patients who had previously been treated with lenalidomide, one achieved a partial response, two achieved a minimal response, four had stable disease, and one had progressive disease. Among patients without prior lenalidomide treatment, the overall response rate was 92%, which included one complete response, two very good partial responses, eight partial responses, and one stable disease.
Common treatment-related adverse events included nausea (58%), decreased appetite (42%), fatigue (38%), decreased weight (38%), vomiting (33%), constipation (25%), and diarrhea (25%). Two patients discontinued treatment due to adverse events.
Disclosure: The study authors’ disclosure information can be found at imw2019boston.org.
