Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
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Sonneveld Pieter, Dimopoulos Meletios A, Boccadoro Mario, Quach Hang, Ho P Joy, Beksac Meral, Hulin Cyrille, Antonioli Elisabetta, Leleu Xavier, Mangiacavalli Silvia, Perrot Aurore, Cavo Michele, Belotti Angelo, Broijl Annemiek, Gay Francesca, Mina Roberto, Nijhof Inger S, van de Donk Niels W C J, Katodritou Eirini, Schjesvold Fredrik, Sureda Balari Anna, Rosiñol Laura, Delforge Michel, Roeloffzen Wilfried, Silzle Tobias, Vangsted Annette, Einsele Hermann, Spencer Andrew, Hajek Roman, Jurczyszyn Artur, Lonergan Sarah, Ahmadi Tahamtan, Liu Yanfang, Wang Jianping, Vieyra Diego, van Brummelen Emilie M J, Vanquickelberghe Veronique, Sitthi-Amorn Anna, de Boer Carla J, Carson Robin, Rodriguez-Otero Paula, Bladé Joan, Moreau Philippe, PERSEUS Trial Investigators
Аннотация
METHODS: In this phase 3 trial, we randomly assigned 709 transplantation-eligible patients with newly diagnosed multiple myeloma to receive either subcutaneous daratumumab combined with VRd induction and consolidation therapy and with lenalidomide maintenance therapy (D-VRd group) or VRd induction and consolidation therapy and lenalidomide maintenance therapy alone (VRd group). The primary end point was progression-free survival. Key secondary end points were a complete response or better and minimal residual disease (MRD)-negative status.
RESULTS: At a median follow-up of 47.5 months, the risk of disease progression or death in the D-VRd group was lower than the risk in the VRd group. The estimated percentage of patients with progression-free survival at 48 months was 84.3% in the D-VRd group and 67.7% in the VRd group (hazard ratio for disease progression or death, 0.42; 95% confidence interval, 0.30 to 0.59; P<0.001); the P value crossed the prespecified stopping boundary (P = 0.0126). The percentage of patients with a complete response or better was higher in the D-VRd group than in the VRd group (87.9% vs. 70.1%, P<0.001), as was the percentage of patients with MRD-negative status (75.2% vs. 47.5%, P<0.001). Death occurred in 34 patients in the D-VRd group and 44 patients in the VRd group. Grade 3 or 4 adverse events occurred in most patients in both groups; the most common were neutropenia (62.1% with D-VRd and 51.0% with VRd) and thrombocytopenia (29.1% and 17.3%, respectively). Serious adverse events occurred in 57.0% of the patients in the D-VRd group and 49.3% of those in the VRd group.
CONCLUSIONS: The addition of subcutaneous daratumumab to VRd induction and consolidation therapy and to lenalidomide maintenance therapy conferred a significant benefit with respect to progression-free survival among transplantation-eligible patients with newly diagnosed multiple myeloma. (Funded by the European Myeloma Network in collaboration with Janssen Research and Development; PERSEUS ClinicalTrials.gov number, NCT03710603; EudraCT number, 2018-002992-16.).