Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE

达拉图穆马 医学 内科学 来那度胺 硼替佐米 微小残留病 多发性骨髓瘤 梅尔法兰 强的松 人口 地塞米松 维持疗法 肿瘤科 外科 胃肠病学 化疗
作者
Jesús F. San-Miguel,Hervé Avet-Loiseau,Bruno Paiva,Shaji Kumar,Meletios A. Dimopoulos,Thierry Facon,Maria-Victoria Mateos,Cyrille Touzeau,Andrzej Jakubowiak,Saad Z. Usmani,Gordon Cook,Michele Cavo,Hang Quach,Jon Ukropec,Priya Ramaswami,Huiling Pei,M. Qi,Steven Sun,Jianping Wang,Maria Krevvata,Nikki A. Deangelis,Christoph Heuck,Rian Van Rampelbergh,Anupa Kudva,Rachel Kobos,Ming Qi,Nizar J. Bahlis
出处
期刊:Blood [American Society of Hematology]
卷期号:139 (4): 492-501 被引量:12
标识
DOI:10.1182/blood.2020010439
摘要

Abstract In patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM), daratumumab reduced the risk of disease progression or death by 44% in MAIA (daratumumab/lenalidomide/dexamethasone [D-Rd]) and 58% in ALCYONE (daratumumab/bortezomib/melphalan/prednisone [D-VMP]). Minimal residual disease (MRD) is a sensitive measure of disease and response to therapy. MRD-negativity status and durability were assessed in MAIA and ALCYONE. MRD assessments using next-generation sequencing (10−5) occurred for patients achieving complete response (CR) or better and after at least CR at 12, 18, 24, and 30 months from the first dose. Progression-free survival (PFS) by MRD status and sustained MRD negativity lasting ≥6 and ≥12 months were analyzed in the intent-to-treat population and among patients achieving at least CR. In MAIA (D-Rd, n = 368; lenalidomide and dexamethasone [Rd], n = 369) and ALCYONE (D-VMP, n = 350; bortezomib/melphalan/prednisone [VMP], n = 356), the median duration of follow-up was 36.4 and 40.1 months, respectively. MRD-negative status and sustained MRD negativity lasting ≥6 and ≥12 months were associated with improved PFS, regardless of treatment group. However, daratumumab-based therapy improved rates of MRD negativity lasting ≥6 months (D-Rd, 14.9% vs Rd, 4.3%; D-VMP, 15.7% vs VMP, 4.5%) and ≥12 months (D-Rd, 10.9% vs Rd, 2.4%; D-VMP, 14.0% vs VMP, 2.8%), both of which translated to improved PFS vs control groups. In a pooled analysis, patients who were MRD negative had improved PFS vs patients who were MRD positive. Patients with NDMM who achieved MRD-negative status or sustained MRD negativity had deep remission and improved clinical outcomes. These trials were registered at www.clinicaltrials.gov as #NCT02252172 (MAIA) and #NCT02195479 (ALCYONE).
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