Real-Life Experience of the Combination of Daratumumab, Bortezomib, Melphalan, and Prednisone (DVMP) in Patients with Newly Diagnosed Multiple Myeloma Ineligible for Autologous Stem-Cell Transplantation

INTRODUCTION The combination of daratumumab, bortezomib, melphalan, and prednisone (D-VMP) is an effective and safe alternative treatment for patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous hematopoietic stem-cell transplantation (HSCT) as described in ALCYONE clinical trial. However, real-life data is limited. This study aims to evaluate the data derived from real-life experience with this combination. METHODS This is a Spanish retrospective, multicenter study. One hundred eleven adults with NDMM ineligible for autologous HSCT who had started first-line treatment with D-VMP from 01/Jun/2019 to 01/Apr/2023 were included. The primary endpoint was to describe the progression-free survival (PFS), and the secondary endpoints were to describe overall response rate (ORR), very good partial response (VGPR), complete response (CR), overall survival (OS), and safety profile. RESULTS A total of 111 patients were included, 57 (51%) were males. The median age was 77 years (IQR 73-82), with 67% ≥ 75 years. Seven percent had an ECOG >2, 6% severe anemia (Hb 2mg/dL, and 7% had a first in-hospital dialysis. Twenty-one (19%) had R-ISS III disease stage, and 22 (20%) had extramedullary disease (16% bone-related plasmacytomas and 4% soft-tissue plasmacytomas). Of the 95 patients evaluable for cytogenetics, 13 (14%) had t(11;14), 36 (38%) had at least one poor-prognosis cytogenetic abnormality (del17p, t(4;14), t(14;16), gan/amp(1q) or del(1p)), and 10 (10%) had > 1. Of all patients, 83 (75%) had completed induction, with a median number of cycles of 9 (IQR 6-9). Among these patients, 26 (23%) received combined maintenance with daratumumab and bortezomib. The ORR was 91%, with at least VGPR in 66% of patients. The ORR and VGPR/CR rates were consistent regardless of age (ORR >74 years 86% vs 74 years 67% vs