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]
日期:2021-07-16
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).