The Outcome of Octogenarian Patients with Multiple Myeloma Treated Outside Clinical Studies, Focusing on Tolerability and Efficacy of Treatment.

Data on the outcome of octogenarian multiple myeloma (MM) patients (pts), especially if treated outside clinical studies, are scanty. : MM pts ≥ 80 years, treated at TASMC with first-line therapy between 2010 and 2023, were reviewed. Characteristics and outcomes were analyzed. A total number of 101 pts, of whom 54 were males with a median age of 84 years (80-98), were included. Among them, 67.4% had a Charlson comorbidity index of ≥5, 37% had ISS-3 (International staging system) and 20% had Revised-ISS-3. In our study, 44.5% received doublets and 50.5% received triplets/quadruplets. A bortezomib-based regimen was applied in 87%, and IMiDs were used in 27.7%. Despite an upfront employment of a low lenalidomide dose, dose reductions were required in 48%. Grade ≥ 3 adverse events (AEs) (mainly infections) were documented in 36.6% of patients, including grade 5 events in 9%, all attributed to infections. The overall response rate was 69%, including 31% ≥ VGPRs (Very good partial response). Sixty-seven percent (67%) received second-line therapy, administered within a median period of 12 months (1-84). Within a median follow-up period of 36 m (1-141), the median overall survival (OS) approached 42 m (range: 1-141); being shorter in pts > 84 years (HR = 1.7, = 0.03), pts with lung disease (HR = 1.8, = 0.044) and pts with ISS = 3 and R-ISS = 3 (HR = 1.65, = 0.0016 and HR = 2.45, = 0.006, respectively); : Octogenarians treated outside clinical studies often have a lower tolerance to treatment. Nevertheless, upfront administration of low doses of anti-MM agents provided a response in the majority of patients, translated into impressive OS. Nevertheless, mortality due to AEs was high, emphasizing the need for new, "octogenarian-oriented" treatment protocols.