Comparing Two Oral Doublet Regimens for Resistant Multiple Myeloma
Posted: Monday, August 2, 2021
Oral ixazomib/dexamethasone prolonged progression-free survival compared with pomalidomide/dexamethasone for patients with heavily pretreated multiple myeloma, but the difference is not statistically significant, according to the findings of a global, multicenter, randomized phase II trial. Meletios A. Dimopoulos, MD, of the University of Athens School of Medicine, and colleagues presented these findings during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8020).
“Ixazomib/dexamethasone was well tolerated, with lower grade 3 or higher adverse event rates versus pomalidomide/dexamethasone, and comparable health-related quality of life,” the authors wrote.
The clinical trial included 122 patients randomly assigned 3:2 to receive oral ixazomib/dexamethasone (73 patients) or oral pomalidomide/dexamethasone (49 patients). All patients had received two or more previous therapies for multiple myeloma (eg, proteasome inhibitors and lenalidomide). Patients took oral treatments on specified days in 28-day cycles until either progressive disease or unacceptable toxicity. Patients received a median of six cycles in both groups.
Median follow-up was 15.3 months for ixazomib/dexamethasone and 17.3 months for pomalidomide/dexamethasone. Median progression-free survival was 7.1 months with ixazomib/dexamethasone compared with 4.8 months with pomalidomide/dexamethasone. The difference was not statistically significant (P = .477).
Fewer patients had grade 3 or higher adverse events on ixazomib/dexamethasone (69%) than on pomalidomide/dexamethasone (81%). A similar number of patients had serious adverse events: 51% with ixazomib/dexamethasone and 53% with pomalidomide/dexamethasone. A total of 13% of patients in each arm died during the study. In the ixazomib/dexamethasone arm, 47% of patients discontinued therapy due to progressive disease and 23% due to adverse events; this was compared with 57% due to progressive disease and 12% due to adverse events in the pomalidomide/dexamethasone arm. Health-related quality of life was similar with the two treatments.
Disclosure: The study authors’ disclosures may be found at coi.asco.org.