Dynamic risk model: a novel approach incorporating functional high risk factors for predicting survival outcomes in patients with relapsed/refractory multiple myeloma

dose modifications, treatment discontinuation, and treatment response.Results: This first interim analysis (as of March 17, 2023) included 37 pts from Italy, Austria, Norway, Germany, Belgium, Spain, and Greece (34 received ≥1 belamaf dose).Mean age was 70.4 years (≥75 years, n=15; 44%); 68% were female.Median time since diagnosis was 86.4 months.Prior therapy data were available for 31 pts (91%): 25 (74%) had ≥4 prior lines of therapy; all 31 had prior exposure to proteasome inhibitors, anti-CD38 therapies (daratumumab 85%), and immunomodulatory therapies; and 91% were triple-class refractory.At baseline, 24 pts (71%) had ≥1 prior/ongoing comorbidity including cardiac disease (n=11; 32%), diabetes (n=10; 29%), eye disease (n=10; 29%), pulmonary disease (n=9; 27%), vascular disorders (n=9; 27%), endocrine disorders (n=7; 21%), and renal disease (n=7; 21%).Most pts (n=29, 85%) saw an ophthalmologist before initiating belamaf; 80%, 78%, and 90% visited an ophthalmologist prior to their 2nd, 3rd and 4th doses.Median treatment time was 4.8 months, and 16 pts (47%) had ≥4 months of follow-up.Overall, 22 pts (65%) reported ocular AESIs including keratopathy (n=16; 47% [Grade ≥2, n=12]), best corrected visual acuity change (n=5; 15%), corneal erosion (n=2; 6%), and dry eye (n=1; 3%).AESIs led to dose reduction in 2 pts (6%) and dose delays in 10 pts (29%).Discontinuation was due to disease progression (n=7; 21%) or AESI (n=3; 9%); 9 pts experienced disease progression or died.Median RW progression-free survival was 3.9 months.Efficacy data are subject to additional follow-up and will be presented.Conclusions: This study demonstrates that in Europe belamaf is used routinely in later lines of therapy, in line with the current approved indication in the EU, including in pts who are aged ≥75 years, have current or prior comorbidities, and/or are triple class refractory.Our data suggest that ocular AEs are being monitored appropriately with ophthalmologist visits and managed using dose modifications.Treatment discontinuations occurred primarily due to progressive disease.