![]() Of 2688 TRAEs, 58 (2.2%) resulted in hospitalization. Of all 3713 TEAEs, 118 (3.2%) led to hospitalization. Serious AEs occurred in 49% of pts, most commonly pneumonia (9%) and febrile neutropenia (5%). In the overall population (N=157), the most frequent grade 3/4 treatment-emergent AEs (TEAEs) were thrombocytopenia (57%), neutropenia (53%), and anemia (43%). Pts hospitalized due to TRAEs had a median age of 63 y (range, 43-84) 31% had International Staging System stage 3 disease 49% had high-risk cytogenetics and 77% had triple-class-refractory MM. Results: At the data cutoff date (), 157 pts were enrolled and had received ≥1 dose of study treatment 35 (22%) had been hospitalized due to a TRAE. AEs were classified as TRAE if reported as related or possibly related to either study drug by the treating physician. Data for specific AEs potentially related to the study drugs (melflufen and/or dex TRAEs) requiring hospitalizations >24 h were compared with all potential TRAEs and within each preferred term with >1 event reported regardless of hospitalization. Methods: Pts with RRMM who had received ≥2 lines of prior therapy, including an IMiD and a proteasome inhibitor and were refractory to pomalidomide and/or an anti-CD38 monoclonal antibody were treated with melflufen and dex as described (Richardson et al. This analysis aids to further elucidate the healthcare resource utilization of pts with RRMM treated with melfulfen in a clinical trial by evaluating the impact of AEs on hospitalizations in HORIZON. In the pivotal, phase 2, HORIZON study (OP-106 NCT02963493), melflufen plus dex showed clinically meaningful efficacy and a safety profile consisting primarily of clinically manageable hematologic AEs in pts with heavily pretreated RRMM (Richardson et al. Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Published data to date come from real-world evidence, with limited reports from clinical trials. Additionally, a real-world study suggested that >50% of pts with hematologic AEs require readmittance to the hospital after initial treatment (Yeaw et al. Inpatient services for the management of AEs are often necessary and a major cost driver, with costs rising per AE episode (highest for hematologic AEs Felber et al. Pts often experience adverse events (AEs) that affect their quality of life and reduce treatment compliance hematologic AEs are frequent. ![]() Background: Pts with RRMM are a very sick population due to disease symptoms, comorbidities, side effects from treatments, and age-related fragility (Chim et al.
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