Phase I Study of New Triplet Therapy for Resistant Myeloma
Posted: Thursday, November 1, 2018
Combining amrubicin—a third-generation anthracycline—with lenalidomide and dexamethasone was found to be safe in 14 adult patients with relapsed or refractory multiple myeloma, according to a phase I, open-label, dose-escalation study. However, although “clinical benefit was observed,” the authors wrote in the International Journal of Hematology, such benefits “appeared limited compared to other newly available therapies.” No phase II studies of this combination therapy are planned.
Agents potentially more effective in the treatment of relapsed or refractory multiple myeloma includehighly selective proteasome inhibitors, such as carfilzomib, and immunomodulatory drugs, including the most potent to date, pomalidomide, noted the team, led by Shira N. Dinner, MD, of Chicago’s Northwestern University Feinberg School of Medicine.
“Pomalidomide in combination with dexamethasone demonstrated a higher response rate compared to our study (33%–35% vs. 21%) in…multiple myeloma patient populations with a median of 5 prior lines of therapy,” explained the investigators. And “as a single agent, carfilzomib produced an overall response rate of 24%” in similar patients; that rate, although considered “low,” was “improved over what we observed with amrubicin, lenalidomide, and dexamethasone,” they added.
Three patients had a partial response or better to the triple therapy, and seven patients had stable disease. The median duration of response was 4.4 months. “Perhaps most disappointing,” the researchers wrote, “our study failed to demonstrate any significant disease control, in that the progression-free survival [rate] was only 3 months—lower than has been reported with dexamethasone alone.”
