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

doi:10.16150/j.1671-2870.2026.01.005

摘要/Abstract

摘要：

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。

关键词: 多发性骨髓瘤, 指南解读, 高危因素, 免疫治疗

Abstract:

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.

Key words: Multiple myeloma, Guideline interpretation, High-risk factors, Immunotherapy

中图分类号:

R446
R733.3

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.

TAO Yi, MI Jianqing. Interpretation of 2026 update of Clinical Practice Guidelines in Oncology： Multiple Myeloma （Version 3） of National Comprehensive Cancer Network[J]. Journal of Diagnostics Concepts & Practice, 2026, 25(01): 30-36.

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对比维度	2025.V2 版指南（旧版）	2026.V1版指南（新版）
新增核心章节	-	新增“特殊人群治疗”章节；新增“MM伴CNS病变”专项诊疗路径；新增“MIDD”管理章节
优化诊断检查	未强制要求NGS检测TP53突变；无明确肾活检指征；	明确NGS检测TP53突变作为初始诊断必做项目；明确“白蛋白尿或肾功能异常时需行肾活检”；
优化危险分层	未纳入IMS-IMWG分层体系；高危定义未明确多种因素组合要求；	纳入IMS-IMWG风险分层标准，优化高危定义，需≥2个传统高危因素才界定为高危（原双打击MM）
优化治疗方案	初诊患者以三药联合为主；复发患者免疫治疗推荐靠后；	初诊患者四药联合优先、复发患者免疫治疗前移
优化随访监测	孤立性浆细胞瘤随访无明确影像评估频次；未明确PET/CT应用节点	软组织/头颈部病变初始3个月后可按需降低频次；明确自体造血干细胞移植后100 d推荐行全身PET/CT；
聚焦支持治疗	感染防控无CAR-T/BsAb专项推荐；肾功能保护无明确骨改良药物剂量调整	明确CAR-T/BsAb治疗相关感染防控细节；明确硼替佐米/达雷妥尤单抗为肾功能不全患者首选，明确唑来膦酸肾损伤患者剂量
重视亚型管理	对孤立性浆细胞瘤、冒烟型骨髓瘤无细化分层管理	孤立性浆细胞瘤细分“伴微小骨髓受累”亚型；冒烟型骨髓瘤按“低危/高危”分层管理，高危人群强化监测与早期干预

风险分层	核心定义
标准风险	未满足高危分层标准的所有患者
高危	满足以下任一条件。 1. del (17p)（浆细胞中占比>20%）和（或）TP53基因突变； 2. t(4;14)、t(14;16)、t(14;20)易位之一合并1q+和（或）del(1p32)； 3. 单等位基因del(1p32)合并1q+，或双等位基因del(1p32)； 4. 高血β₂微球蛋白（>5.5 mg/dL）且血肌酐正常（<1.2 mg/dL）（1 L=10 dL）