EMN09 Study: Is Carfilzomib, Bendamustine, and Dexamethasone Effective in Treating Advanced Myeloma?
Posted: Tuesday, August 17, 2021
Despite recent advances, limited treatment options remain for patients with advanced multiple myeloma. Francesca Gay, MD, and colleagues from the University of Torino, Italy, found that combination treatment using carfilzomib, bendamustine, and dexamethasone appears to be an effective treatment in the outpatient setting for this patient population. However, they cautioned, infection prophylaxis and attention to those with cardiovascular predisposition are necessary. Their results were published in the journal Cancer.
The phase I/II EMN09 study enrolled patients with relapsed and/or refractory multiple myeloma within the European Myeloma Network. Patients received 20 mg of oral dexamethasone on days 1, 2, 8, 9, 15, 16, 22, and 23. A 27-mg/m2 intravenous carfilzomib dose was given on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. A 70-mg/m2 fixed dose on days 1 and 8 of a 28-day cycle of bendamustine was given intravenously. Phase II administered combination treatment at the maximum tolerated dose (MTD) for 8 cycles along with carfilzomib at the MTD on days 1, 2, 15, and 16 plus dexamethasone. A total of 13 patients were enrolled in phase I (dose escalation), and 50 patients were included in phase II.
Phase I results determined that 27 mg/m2 of carfilzomib twice weekly in weeks 1, 2, and 3 was the recommended phase II dose. A very good or better response was seen in 32% of patients, and a partial response or better was seen in 52% of patients. The median progression-free survival was 11.6 months, and the median overall survival was 30.4 months.
Treatment-related adverse effects associated with the combination treatment were mostly grade 1 or 2. Hematologic grade 3 or 4 toxicities during treatment included lymphopenia, neutropenia, thrombocytopenia, and anemia. The nonhematologic grade 3 or 4 toxicities observed were pneumonia, thromboembolic events, cardiac adverse events, and hypertension.
Disclosure: For full disclosures of the study authors, visit acsjournals.onlinelibrary.wiley.com.