Posted: Friday, June 17, 2022
Treatment with ixazomib and daratumumab without dexamethasone seems to be a feasible combination for frail elderly patients with relapsed or refractory multiple myeloma—even in those with high-risk cytogenetics and lenalidomide-refractory disease. Xavier Leleu MD, PhD, of Poitiers University Hospital, France, and colleagues presented the findings of the Intergroupe Francophone du Myélome (IFM) 2018–2021 study at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract 8000).
A total of 55 patients with ixazomib- and daratumumab-naive relapsed or refractory multiple myeloma were enrolled in the phase II trial after their first (n = 36) or second (n = 19) relapse. Participants received oral ixazomib, intravenous daratumumab, and intravenous methylprednisolone prior to each dose of daratumumab.
Nearly one-quarter of patients (24%) had an International Myeloma Working Group frailty score of 3 or 4; the remainder had a frailty score of 2. The median patient age was 82. Most patients had previous exposure to bortezomib (60%) and/or lenalidomide (67%).
The objective response rate—including minimal response—was 86%, and 32% of patients had a very good partial response rate or better. In patients with lenalidomide-refractory disease and those with high-risk cytogenetics, the objective response rates were 82% and 85%, respectively, and the rates of a very good partial response or better were 41% and 46%, respectively. Median progression-free survival was 16 months, and median overall survival was not reached.
As for toxicity, grade 3 or higher treatment-related adverse events were reported in half of patients (49%). The most common grade 3 or 4 toxicities were thrombocytopenia (n = 9), other cytopenias (n = 4), infection (n = 8), hypertension (n = 3), and gastrointestinal disorders (n = 3). “Early toxicity remains a concern in this population,” concluded the study authors.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.