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4745 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 TransplantationClinically Relevant Abstract

Program: Oral and Poster Abstracts
Session: 652. Multiple Myeloma: Clinical and Epidemiological: Poster III
Hematology Disease Topics & Pathways:
Clinical Practice (Health Services and Quality), elderly, Combination therapy, Therapies, Adverse Events, Study Population, Human
Monday, December 11, 2023, 6:00 PM-8:00 PM

Amalia Domingo-González1*, Rafael Alonso Fernández, MD2*, Ana Jiménez3*, Teresa De Soto Alvarez4*, Ana Lerma5*, Virginia Pradillo Fernandez6*, Gonzalo Benzo Callejo7*, Jose Sanchez-Pina2*, Elena Landete8*, Alberto Velasco9*, Marina Menéndez Cuevas9*, Mónica María López Riñón10*, Andrés Ramírez López11*, Alberto Lopez Garcia, MD1, María-Jesús Blanchard3* and Elham Askari, MD1*

1Fundacion Jimenez Diaz University Hospital, Madrid, Spain
2Department of Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain
3Hematology, Hospital Universitario Ramon y Cajal, Madrid, Spain
4Hospital Universitario La Paz, Madrid, ESP
5Hospital General Nuestra Señora del Prado, Toledo, Spain
6Hospital Universitario Quirón Pozuelo, Madrid, ESP
7Hospital Universitario La Princesa, Galdakao, ESP
8Hospital Universitario Infanta Leonor, Madrid, Spain
9Hospital Rey Juan Carlos, Madrid, Spain
10Hospital General de Tomelloso, Ciudad Real, Spain
11Hospital General La Mancha Centro, Ciudad Real, Spain


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.


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.


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 <7.5g/dL), 14% creatinine >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 <75 years 92%; VGPR/CR >74 years 67% vs <75 years 62%) and cytogenetic risk (ORR high-risk cytogenetic 86% vs standard cytogenetic 94%; VGPR/CR high risk cytogenetic 64% vs standard cytogenetic 68%). The median time to response was 35 days (IQR 24-49), and the median time to best response was 206 days (IQR 91-458). Minimal residual disease (MRD) was determined in 27 (54%) of patients in CR and 6 (26%) in VGPR. Eighteen patients in CR and 1 patient in VGPR had negative MRD (at least 10-4). Twelve patients with negative MRD were subsequently re-evaluated, and 7 maintained MRD negativity at 4 (1), 6 (2), 9 (2), 12 (1) and 24 (1) months. Median OS was 44 months (95% confidence interval [CI], 33 to 55) and median PFS was 28 months (95% CI, 21 to 36). At a median follow-up of 22,6 months (IQR 15-30), the 36-month OS rate was 60% (95% CI, 52 to 68). Median OS was 36 months (95% CI 24 to 45) in the high cytogenetic risk group. Median PFS was 22 months (IC 95% 7 to 38) in the high cytogenetic risk group and 9 months (IC 95% 0 to 22) in the group with > 1 poor-prognosis cytogenetic abnormality. The dose of bortezomib was reduced in 42% of patients, mainly due to neuropathy (42%). The dose of melphalan was reduced in 28%, mainly because of myelotoxicity (29%) and kidney failure (19%). Both bortezomib and melphalan were discontinued in 6% of patients. Daratumumab did not require adjustment or early suspension. There were 13 deaths (12%), 4 due to progression, 4 due to infection, and 5 due to a cause unrelated to the MM. Among 24 (22%) of total patients who experienced relapse, 96% received subsequent therapy. The most frequent therapy was Lenalidomide-Dexamethasone (46%) followed by Carfilzomib-Lenalidomide-Dexamethasone (38%).


In real-life practice, D-VMP combination in patients with NDMM ineligible for transplant showed comparable efficacy and safety profile with those reported in ALCYONE clinical trial. Although the PFS and OS data are lower than those reported in ALCYONE, this could be due to the older age and a worse clinical involvement of the patients included in this study.

Disclosures: Lopez Garcia: Beigene: Consultancy; Janssen: Consultancy, Speakers Bureau; Astrazeneca: Consultancy, Speakers Bureau; Roche: Consultancy, Speakers Bureau.

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