Abstract
This post-marketing surveillance (PMS) assessed the safety and effectiveness of isatuximab plus pomalidomide and dexamethasone (Isa-Pd) for relapsed or refractory multiple myeloma (RRMM) in frail individuals during real-world use in Japan. Data from all individuals with RRMM treated with Isa-Pd in Japan between October 2020 and October 2021 were collected, with follow-up continued up to 12 months after starting Isa-Pd or until discontinuation. In the overall PMS population, 40 participants were classified as frail (33.3%) and 29 as fit/intermediate (24.2%), and 51 had no frailty score (42.5%). Incidence of adverse drug reactions in each group was 77.5%, 65.5%, and 37.3%. In frail versus fit/intermediate participants, bone-marrow suppression occurred in 72.5% versus 44.8%, infectious diseases in 17.5% versus 10.3%, and infusion-related reactions in 7.5% versus 3.5%. Heart failure occurred in one participant with no frailty score. The rates of overall response and very good partial response or better were higher (p = 0.101) in fit/intermediate participants (56.0% and 36.0%) than in frail participants (38.5% and 18.0%). Rates of treatment discontinuation due to disease progression were similar between groups. These findings support the safety and effectiveness of Isa-Pd for frail individuals with RRMM in real-life settings in Japan.