2026年美国国立综合癌症网络《多发性骨髓瘤指南》(第3版)更新解读
收稿日期: 2025-12-16
修回日期: 2026-01-09
录用日期: 2026-01-12
网络出版日期: 2026-02-25
基金资助
国家自然科学基金(82470206);上海市血液病学临床专科能力提升项目(SHDC22024314)
Interpretation of 2026 update of Clinical Practice Guidelines in Oncology: Multiple Myeloma (Version 3) of National Comprehensive Cancer Network
Received date: 2025-12-16
Revised date: 2026-01-09
Accepted date: 2026-01-12
Online published: 2026-02-25
全球及中国多发性骨髓瘤(multiple myeloma, MM)疾病负担呈持续上升趋势。2021年,全球MM新发病例达148 754.63例,死亡病例为116 359.63例;中国新发病例为17 250例,死亡病例为12 984例。男性、老年人群及经济发达地区负担更重,年轻人群患病趋势值得关注,预计未来MM的疾病负担仍将增加,高体质量指数是重要关联风险因素。2025年,美国国立综合癌症网络(National Comprehensive Cancer Network, NCCN)发布的《多发性骨髓瘤临床实践指南》经Version 1.2026版(以下简称2026.V1)至Version 3.2026版(2026.V3)快速迭代,内容覆盖了多发性骨髓瘤(multiple myeloma, MM)诊疗的全流程。笔者对2026.V1版指南与2025.V2版指南进行比较、解读,并补充对2026.V2及2026.V3版更新内容的解读,期望助力临床医师提升MM诊治水平,优化高危MM患者管理,进一步改善我国MM患者群体预后。本文的核心内容可概括为“三新增、四优化、两聚焦、一重视”,“三新增”包括特殊人群个体化治疗、多发性骨髓瘤伴中枢神经系统(central nervous system, CNS)病变诊疗路径以及免疫球蛋白沉积病(monoclonal immunoglobulin deposition disease, MIDD)管理的内容新增;“四优化”包括诊断检查强化第二代测序(next-generation sequencing, NGS)与肾活检应用,高危风险分层纳入国际骨髓瘤协会-国际骨髓瘤工作组(International Myeloma Society - International Myeloma Working Group, IMS-IMWG)标准以精准筛选高危患者,治疗方案强调初诊患者四药联合优先、复发患者免疫治疗前移,随访监测明确PET/CT应用时机;“两聚焦”指聚焦感染预防[细化嵌合抗原受体T细胞治疗(chimeric antigen receptor T cell therapy, CAR-T)等治疗相关感染防控]和肾功能保护(明确首选药物及骨改良药物剂量);一重视则是指重视孤立性浆细胞瘤和冒烟型骨髓瘤亚型管理。2026.V1指南以“精准、多元、全程”为核心,强调了多学科协作与个体化治疗,2026.V2、2026.V3版则进一步优化了复发难治患者的药物推荐。
陶怡 , 糜坚青 . 2026年美国国立综合癌症网络《多发性骨髓瘤指南》(第3版)更新解读[J]. 诊断学理论与实践, 2026 , 25(01) : 30 -36 . DOI: 10.16150/j.1671-2870.2026.01.005
The disease burden of multiple myeloma (MM) has been continuously increasing globally and in China. In 2021, the number of newly-diagnosed MM cases globally reached 148 754.63, and the number of deaths was 116 359.63. In China, the number of newly-diagnosed cases was 17 250, and the number of deaths was 12 984. The burden is heavier in males, elderly populations, and economically developed regions, while the rising prevalence in younger populations also deserves attention. The disease burden of MM is expected to continue to increase in the future, with high body mass index being an important associated risk factor. In 2025, the "Clinical Practice Guidelines in Oncology: Multiple Myeloma" issued by the National Comprehensive Cancer Network (NCCN) underwent rapid iterations from Version 1.2026 (hereafter referred to as 2026.V1) to Version 3.2026 (2026.V3), covering the entire process of MM diagnosis and treatment. This study compares and interprets the 2026.V1 guideline with the 2025.V2 version, and supplements the interpretation of updates in 2026.V2 and 2026.V3, aiming to help clinicians improve MM diagnosis and treatment, optimize the management of high-risk MM patients, and further enhance the prognosis of MM patients in China. The core content of this study can be summarized as "three additions, four optimizations, two focuses, and one emphasis". The "three additions" include the incorporation of individualized treatment for special populations, diagnostic and therapeutic pathways for MM with central nervous system (CNS) involvement, and management of monoclonal immunoglobulin deposition disease (MIDD). The "four optimizations" include strengthening the application of next-generation sequencing (NGS) and renal biopsy in diagnostic examination, incorporating International Myeloma Society/International Myeloma Working Group (IMS-IMWG) criteria in high-risk stratification for precise identification of high-risk patients, emphasizing four-drug combination priority for newly diagnosed patients and earlier use of immunotherapy for relapsed patients in treatment regimens, and clarifying the timing of PET/CT application in follow-up monitoring. The "two focuses" refer to focusing on infection prevention (refining infection control for treatments such as chimeric antigen receptor T cell therapy [CAR-T]) and renal function protection (clarif-ying preferred drugs and doses of bone-modifying agents). The "one emphasis" refers to giving attention to the management of solitary plasmacytoma and smoldering myeloma subtypes. The 2026.V1 guideline focuses on "precision, diversity, and whole-course management", highlighting multidisciplinary collaboration and individualized treatment, while the 2026.V2 and 2026.V3 further optimize drug recommendations for relapsed/refractory patients.
| [1] | DOU X, DUAN G, ZHONG Y, et al. The burden of multiple myeloma in China: Trends from 1990 to 2021 and forecasts for 2050[J]. Cancer Lett, 2025,611:217440. |
| [2] | HOU Q, LI X, MA H, et al. A systematic epidemiological trends analysis study in global burden of multiple myeloma and 29 years forecast[J]. Sci Rep, 2025,15:2204. |
| [3] | PALUMBO A, BRINGHEN S, MATEOS M V, et al. Geriatric assessment predicts survival and toxicities in elderly myeloma patients: an International Myeloma Working Group report[J]. Blood, 2015; 125(13):2068-2074. |
| [4] | ENGELHARDT M, DOLD S M, IHORST G, et al. Geriatric assessment in multiple myeloma patients: Validation of the International Myeloma Working Group (IMWG) score and comparison with other common comorbidity scores[J]. Haematologica, 2016, 101(9):1110-1119. |
| [5] | ZHANG Y, LIANG X, XU W, et al. Individualized dynamic frailty-tailored therapy (DynaFiT) in elderly patients with newly diagnosed multiple myeloma: A prospective study[J]. J Hematol Oncol, 2024, 17(1):48. |
| [6] | PERES L C, OSWALD L B, DILLARD C M, et al. Racial and ethnic differences in clinical outcomes among patients with multiple myeloma treated with CAR T-cell therapy[J]. Blood Adv, 2024, 8(1):251-259. |
| [7] | ELHAMMALI A, AMINI B, LUDMIR E B, et al. New paradigm for radiation in multiple myeloma: Lower yet effective dose to avoid radiation toxicity[J]. Haematologica, 2020, 105(7):e355-e357. |
| [8] | KATODRITOU E, TERPOS E. Central nervous system myeloma: Pathogenesis, diagnostic challenges, and practical management strategies[J]. HemaSphere, 2025, 9(10):e70213. |
| [9] | LI X M, RUI H C, LIANG D D, et al. Clinicopathological characteristics and outcomes of light chain deposition di-sease: an analysis of 48 patients in a single Chinese center[J]. Ann Hematol, 2016, 95(6):901-909. |
| [10] | SCHAVGOULIDZE A, PERROT A, LELEU X, et al. High-risk genomic consensus validation for patients with newly diagnosed multiple myeloma using next-generation sequencing[J]. Blood, 2026, 147(3):266-275. |
| [11] | DIMOPOULOS M A, MERLINI G, BRIDOUX F, et al. Management of multiple myeloma-related renal impairment: Recommendations from the International Myeloma Working Group[J]. Lancet Oncol, 2023, 24(7):e293-e311. |
| [12] | AVET-LOISEAU H, DAVIES F E, SAMUR M K, et al. International myeloma society/international myeloma working group consensus recommendations on the definition of high-risk multiple myeloma[J]. J Clin Oncol, 2025, 43(24):2739-2751. |
| [13] | TAO Y, JIN S, YANG D, et al. Real-world advantage and challenge of post-autologous stem cell transplantation MRD negativity in high-risk patients with double-hit multiple myeloma[J]. BMC Cancer, 2024, 24(1):406. |
| [14] | TAO Y, JIN S W, WANG Z, et al. Exploring secondary extramedullary myeloma disease: A five-predictor scoring system with spotlight on double-hit cytogenetics[J]. BMC Med, 2025, 23(1):257. |
| [15] | MAI E K, BERTSCH U, POZEK E, et al. Isatuximab, Lenalidomide, bortezomib, and dexamethasone induction therapy for transplant-eligible newly diagnosed multiple myeloma: Final part 1 analysis of the GMMG-HD7 trial[J]. J Clin Oncol, 2025, 43(11):1279-1288. |
| [16] | BADROS A, FOSTER L, ANDERSON L D JR, et al. Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: The AURIGA study[J]. Blood, 2025, 145(3):300-310. |
| [17] | LESOKHIN A M, TOMASSON M H, ARNULF B, et al. Elranatamab in relapsed or refractory multiple myeloma: Phase 2 MagnetisMM-3 trial results[J]. Nat Med, 2023, 29(9):2259-2267. |
| [18] | CHARI A, MINNEMA M C, BERDEJA J G, et al. Talque-tamab, a T-cell-redirecting GPRC5D bispecific antibody for multiple myeloma[J]. N Engl J Med, 2022, 387(24):2232-2244. |
| [19] | BERDEJA J G, MADDURI D, USMANI S Z, et al. Cilta-cabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): A phase 1b/2 open-label study[J]. Lancet, 2021, 398(10297):314-324. |
| [20] | LEE A. Linvoseltamab: First approval[J]. Drugs, 2025, 85(10):1329-1333. |
| [21] | HUNGRIA V, ROBAK P, HUS M, et al. Belantamab mafodotin plus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): Updated overall survival analysis from a global, randomised, open-label, phase 3 trial[J]. Lancet Oncol, 2025, 26(8):1067-1080. |
| [22] | 陶怡, 金诗炜, 王焰, 等. 髓外病变对初诊多发性骨髓瘤患者预后的影响[J]. 中华血液学杂志, 2023, 44(1):48-54. |
| TAO Y, JIN S W, WANG Y, et al. Effects of extramedullary disease on patients with newly diagnosed multiple myeloma[J]. Chin J Hematol, 2023, 44(1):48-54. | |
| [23] | MOHAN M, NAGAVALLY S, DHAKAL B, et al. Risk of infections with B-cell maturation antigen-directed immunotherapy in multiple myeloma[J]. Blood Adv, 2022, 6(8):2466-2470. |
| [24] | KIM E B, MALESPINI J E, LEI M, et al. Early daratumumab therapy improves renal outcomes in newly diagnosed patients with myeloma admitted with kidney injury[J]. Blood Adv, 2025, 9(13):3129-3135. |
| [25] | WALKER R, BARLOGIE B, HAESSLER J, et al. Magnetic resonance imaging in multiple myeloma: Diagnostic and clinical implications[J]. J Clin Oncol, 2007, 25(9):1121-1128. |
| [26] | LAKSHMAN A, RAJKUMAR S V, BUADI F K, et al. Risk stratification of smoldering multiple myeloma incorporating revised IMWG diagnostic criteria[J]. Blood Cancer J, 2018, 8(6):59. |
| [27] | MATEOS M V, KUMAR S, DIMOPOULOS M A, et al. International Myeloma Working Group risk stratification model for smoldering multiple myeloma (SMM)[J]. Blood Cancer J, 2020, 10(10):102. |
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