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2011NCCN 多发性骨髓瘤

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2011NCCN 多发性骨髓瘤 Copyright © National Comprehensive Cancer Network 2011. All rights reserved. “NCCN”, the NCCN logo, and “National Comprehensive Cancer Network” are registered trademarks of the National Comprehensive Cancer Network. The Chinese edition of NCCN Clinical Practi...
2011NCCN 多发性骨髓瘤
Copyright © National Comprehensive Cancer Network 2011. All rights reserved. “NCCN”, the NCCN logo, and “National Comprehensive Cancer Network” are registered trademarks of the National Comprehensive Cancer Network. The Chinese edition of NCCN Clinical Practice Guidelines in Oncology-Multiple Myeloma Guideline 2011 is the Chinese adapted version of NCCN Clinical Practice Guidelines in Oncology-Multiple Myeloma Guideline, V.1.2011 as permitted and endorsed by NCCN. It is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. The original guideline and Chinese edition are both available at: http://www.nccn.org. To view the most recent and complete version of the guideline, go online to www.nccn.org. These Guidelines and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. These Guidelines are a work in progress that will be refined as often as new significant data becomes available. The NCCN Guidelines are a statement of consensus of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN guideline is expected to use independent medical judgment in the context of individual clinical circumstance to determine any patient's care or treatment. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. This publication should not be used for commercial purpose. It is provided for free to Chinese medical professions with the support of the unrestrictive educational grant of Celgene Pharmaceutical (Shanghai) Co. Ltd. which exerts no influence to the formation of the Chinese edition of NCCN Clinical Practice Guidelines in Oncology- Multiple Myeloma Guideline 2011. © National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. The Chinese edition 2011 is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. Translated and adapted with permission and endorsement from the National Comprehensive Cancer Network. To view the most recent and complete version of this or any other guideline, visit www.nccn.org. 多发性骨髓瘤 NCCN多发性骨髓瘤专家组成员 *Kenneth C. Anderson, MD/Chair ‡ Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center Melissa Alsina, MD ‡ H. Lee Moffitt Cancer Center & Research Institute William Bensinger, MD † ξ Fred Hutchinson Cancer Research Center/ Seattle Cancer Care Alliance J. Sybil Biermann, MD ¶ University of Michigan Comprehensive Cancer Center Asher Chanan-Khan, MD † Roswell Park Cancer Institute Adam D. Cohen, MD Fox Chase Cancer Center Steven Devine, MD † The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute Benjamin Djulbegovic, MD , PhD † ‡ ξ H. Lee Moffitt Cancer Center & Research Institute Edward A. Faber, Jr., DO ‡ UNMC Eppley Cancer Center at The Nebraska Medical Center Carol Ann Huff, MD † The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Adetola Kassim, MD ‡ ξ Vanderbilt-Ingram Cancer Center Gwynn Long, MD † Duke Comprehensive Cancer Center Bruno C. Medeiros, MD ‡ Stanford Comprehensive Cancer Center Ruby Meredith, MD, PhD § Univers i ty o f A labama a t B i rmingham Comprehensive Cancer Center Noopur Raje, MD † ‡ Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center Jeffrey Schriber, MD ‡ ξ City of Hope Comprehensive Cancer Center Seema Singhal, MD ‡ Robert H. Lurie Comprehensive Cancer Center of Northwestern University George Somlo, MD † ‡ Þ City of Hope Comprehensive Cancer Center Keith Stockerl-Goldstein, MD † ξ Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine Steven P. Treon, MD, PhD † Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center Guido Tricot, MD, PhD ‡ Huntsman Cancer Institute at the University of Utah Donna Weber, MD † ‡ Þ The University of Texas M. D. Anderson Cancer Center Joachim Yahalom, MD § Memorial Sloan-Kettering Cancer Center Furhan Yunus, MD St. Jude Children’s Research Hospital/ University of Tennessee Cancer Institute NCCN Staff Rashmi Kumar, PhD Dorothy A. Shead, MS † 肿瘤内科 ‡ 血液科 ξ 骨髓移植 ¶ 外科/肿瘤外科 § 放疗/肿瘤放疗科 € 儿童肿瘤科 Þ 内科 * 编委会成员 © National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. The Chinese edition 2011 is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. Translated and adapted with permission and endorsement from the National Comprehensive Cancer Network. To view the most recent and complete version of this or any other guideline, visit www.nccn.org. 多发性骨髓瘤 NCCN特别鸣谢 NCCN指南中国版专家组 召集人: 孙 燕 中国医学科学院北京协和医学院 肿瘤医院 NCCN代: Seema Singhal, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University 组长: 沈志祥 上海交通大学医学院附属瑞金医院 黄晓军 北京大学人民医院 执行组长: 王建祥 中国医学科学院北京协和医学院血液学研究所血液病医院 侯 健 第二军医大学第二附属医院、上海长征医院 成 员(按拼音排序): 蔡 真 浙江大学医学院附属第一医院 陈协群 第四军医大学西京医院 李建勇 江苏省人民医院 刘 霆 四川大学华西医院 路 谨 北京大学人民医院 马 军 哈尔滨血液病肿瘤研究所 执笔人: 邱录贵 中国医学科学院北京协和医学院血液学研究所血液病医院 陈文明 首都医科大学附属北京朝阳医院 李 娟 中山大学附属第一医院 王健民 第二军医大学第一附属医院、上海长海医院 吴德沛 苏州大学附属第一医院 于 力 中国人民解放军总医院(三○一医院) 周道斌 中国医学科学院北京协和医学院北京协和医院 邹 萍 华中科技大学同济医学院附属协和医院 NCCN多发性骨髓瘤临床实践指南(中国版)专家组 © National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. The Chinese edition 2011 is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. Translated and adapted with permission and endorsement from the National Comprehensive Cancer Network. To view the most recent and complete version of this or any other guideline, visit www.nccn.org. 多发性骨髓瘤 目录 NCCN多发性骨髓瘤专家组成员 NCCN特别鸣谢 多发性骨髓瘤: 初诊检查和临床表现(MYEL-1) 骨或骨外孤立性浆细胞瘤:初始治疗(MYEL-2) 多发性骨髓瘤:诱导治疗和随访(MYEL-3) 随访和监测(MYEL-4) 干细胞移植后的进一步治疗(MYEL-5) 活动性骨髓瘤:进展后的进一步治疗(MYEL-6) 多发性骨髓瘤分期系统(MYEL-A) 多发性骨髓瘤定义(冒烟型和活动性)(MYEL-B) 多发性骨髓瘤疗效(MYEL-C) 骨髓瘤的治疗(MYEL-D) 辅助性治疗(MYEL-E) 系统性轻链型淀粉样变: 检查和治疗(AMYL-1) 讨论(MS-1) 参考文献(REF-1) 临床试验:NCCN认为任何肿瘤患者都可以在临床试验中得到最 佳处理,因此特别鼓励肿瘤患者参加临床试验。 NCCN对证据和共识的分类: 除非特别指出,NCCN对所有建议均达成2A类共识。 见NCCN对证据和共识的分类 作为共识,NCCN肿瘤学临床实践指南反映了作者们对目前认可的治疗方法的观点,欲参考或应用这些指南的临床医师应根据个人具体的临床情况做出独立的医疗判断,以决定患者所需的护理和治 疗。任何寻求使用这些指南的病人或非医生人员应咨询医生关于它们的合理应用。 NCCN肿瘤学临床实践指南编译力求精确表达反映原版英文指南。NCCN不保证指南编译的有效性,也不承认任何无限制性的担保、表达及暗示。NCCN不担保指南编译或指南本身的精确性和完整 性。NCCN不保证或担保或陈述指南的应用及应用结果。NCCN及其成员不对涉及指南无限制性应用的任何偶然的、间接的、特殊的、惩罚性或作为结果的补偿费承担任何责任。 声明: 本指南中标注“※”处为中国专家根据国内实际情况进行明显 改动或补充之处,内容有别于英文版,参考时请注意。 © National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. The Chinese edition 2011 is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. Translated and adapted with permission and endorsement from the National Comprehensive Cancer Network. To view the most recent and complete version of this or any other guideline, visit www.nccn.org. 多发性骨髓瘤 MYEL-1 初诊检查 活动性(有症状性)a,d ● 病史和体格检查 ● 全血细胞计数、分类、血小板 ● 尿素氮/肌酐、电解质 ● LDH ● 血清钙/白蛋白 ● β2微球蛋白 ● 24小时尿总蛋白 ● 血清游离轻链 ● 血清免疫球蛋白定量分析、血清蛋白 电泳(SPEP)、血清免疫固定电泳 (SIFE) ● 24小时尿总蛋白、尿蛋白电泳(UPEP) 和尿免疫固定电泳(UIFE) ● 骨骼检查 ● 单侧骨髓穿刺+活检,包括骨髓免疫组化 和/或骨髓流式细胞术检测 ● 细胞遗传学检查 ● 荧光原位杂交(FISH)[del 13、del 17、 t(4;14)、t(11;14)、1q21扩增] 孤立性浆细胞瘤a 冒烟型(无症状性)a,b,c 见骨孤立性浆细胞瘤: 初始治疗(MYEL-2) 见骨外孤立性浆细 胞瘤:初始治疗 (MYEL-2) 见初始治疗(MYEL-3) 适用于某些临床情况 ● MRI适用于疑似椎体压缩 ● CT扫描(避免使用造影剂) ● PET/CT扫描 ● 组织活检以诊断骨或骨外孤立性 浆细胞瘤 ● 骨密度测定 ● 浆细胞标记指数 ● 骨髓和脂肪垫染色检测淀粉样变 ● 血粘度 ● HLA分型检查 a见多发性骨髓瘤分期系统(MYEL-A)。 b见冒烟型(无症状性)骨髓瘤(MYEL-B)。 c包括Durie-Salmon分期为I期的骨髓瘤。 d见活动性(有症状性)骨髓瘤(MYEL-B)。 临床表现 © National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. The Chinese edition 2011 is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. Translated and adapted with permission and endorsement from the National Comprehensive Cancer Network. To view the most recent and complete version of this or any other guideline, visit www.nccn.org. 多发性骨髓瘤 MYEL-2 临床表现 e见多发性骨髓瘤疗效标准(MYEL-C)。 骨孤立性 浆细胞瘤 ● 全血细胞计数 ● 血清肌酐、白蛋白、LDH、血 钙、β2微球蛋白测定 ● 考虑血清游离轻链测定 ● 24小时尿总蛋白、尿蛋白电泳 (UPEP)和尿免疫固定电泳 (UIFE) ● 血清免疫球蛋白定量分析、血 清蛋白电泳(SPEP)、血清免 疫固定电泳(SIFE) ● 有临床指征时考虑进行骨髓活 检 ● 考虑每年1次或有临床指征时进 行骨骼检查 ● 考虑每6~12个月1次或有临床指 征时进行MRI和/或CT和/或PET- CT检查 原发进展e 或 缓解后进展e 骨髓瘤重新分期 见活动性(有症 状性)骨髓瘤 (MYEL-3) 初始治疗 随访/监测 骨外孤立性 浆细胞瘤 受累野放疗 (≥45 Gy) 受累野放疗 (≥45 Gy) 和/或手术 © National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. The Chinese edition 2011 is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. Translated and adapted with permission and endorsement from the National Comprehensive Cancer Network. To view the most recent and complete version of this or any other guideline, visit www.nccn.org. 多发性骨髓瘤 临床表现 冒烟型 (无症状性) 骨髓瘤a,b,c ● 免疫球蛋白定量+M蛋白定量分析 (血清及尿液) ● 全血细胞计数、分类、血小板 ● 尿素氮、肌酐、血钙 ● 每年1次或有症状时进行骨骼检查 ● 有临床指征时进行骨髓活检 ● 考虑游离轻链测定 ● 考虑MRI ● 考虑PET-CT扫描 进展至有症 状性骨髓瘤d 见以下活动性(有 症状性)骨髓瘤 诱导治疗 随访/监测 活动性 (有症状性) 骨髓瘤a,d 观察间隔为 3~6个月 (1类) 诱导治疗f, 双膦酸盐g+有 指征时联合辅 助性治疗g ● 免疫球蛋白定量+M蛋白定量分析 (血清及尿液) ● 全血细胞计数、分类、血小板 ● 尿素氮、肌酐、血钙 ● 每年1次或有症状时进行骨骼检查 ● 有临床指征时进行骨髓活检 ● 考虑游离轻链测定 ● 考虑MRI ● 考虑PET-CT扫描 如适合移植(由 干细胞移植中心 评估),干细胞 采集(满足2次 移植所需) 诱导治疗 后缓解e 诱导治疗 后无缓解e 见进一步治疗 (MYEL-4) 见进一步治疗 (MYEL-6) a见多发性骨髓瘤分期系统(MYEL-A)。 b见冒烟型(无症状性)骨髓瘤(MYEL-B)。 c包括Durie-Salmon分期为I期的骨髓瘤。 d见活动性(有症状性)骨髓瘤(MYEL-B)。 e见多发性骨髓瘤疗效标准(MYEL-C)。 f见骨髓瘤的治疗(MYEL-D)。 g见辅助性治疗(MYEL-E)。 MYEL-3 © National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. The Chinese edition 2011 is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. Translated and adapted with permission and endorsement from the National Comprehensive Cancer Network. To view the most recent and complete version of this or any other guideline, visit www.nccn.org. 多发性骨髓瘤 h由Bruno等(NEJM 2007;356:1110-1120)开展的一项前瞻性研究发现,与进行双次序贯自体移植的患者相比,接受自体移植序贯非清髓异基因移植的患者生存改善。由Garban等(Blood 2006:107:3474)开展的IFM试验(99-03)报道了在高危骨髓瘤患者中进行自体移植序贯异基因小移植无总生存和无进展生存的获益。 i异基因干细胞移植可包括自体干细胞移植后进行的非清髓性异基因干细胞移植(小移植)或临床试验中的清髓性异基因干细胞移植(临床试验以外为3类共识)。目前数据不支持单独应用异基因小移植。 j自体干细胞移植:1类证据支持诱导治疗后直接进行大剂量治疗及干细胞移植,而非将干细胞移植留待挽救治疗阶段。证据提示,尽管早期移植能够延长无进展生存期,但总生存期并无差异。 Fermand JP, Katsahian S, Divine M, et al. High dose therapy and autologous blood stem cell transplantation compared with conventional treatment in myeloma patients aged 55 to 65 years: Long term results of a randomized control trial from the Group Myelome-Autogreffe. J Clin Oncol 2005;23:9227-9233. Barlogie B, Kyle RA, Anderson KC, et al. Standard chemotherapy compared with high-dose chemoradiotherapy for multiple myeloma: final results of phase III US Intergroup Trial S9321. J Clin Oncol. 2006;24:929-936. k肾功能不全及老年并非移植的禁忌证。 诱导治疗后缓解 在临床试验中进行异基 因干细胞移植h,i 或 自体j,k干细胞移植 (1类) ● 至少每3月进行1次免疫球蛋白定量 +M蛋白定量分析 ● 全血细胞计数、分类、血小板 ● 尿素氮、肌酐、血钙 ● 每年1次或有症状时进行骨骼检查 ● 有临床指征时进行骨髓活检 ● 考虑游离轻链测定 ● 考虑MRI ● 考虑PET/CT扫描 活动性(有症状 性)骨髓瘤 随访/监测 或 继续诱导治疗直至 达平台期 见异基因干细胞移植和自体干细胞 移植后的进一步治疗(MYEL-5) 如上所述进行监测和/或维持治疗 (首选临床研究) 见诱导治疗后的进一步治疗 (MYEL-6) MYEL-4 © National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. The Chinese edition 2011 is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. Translated and adapted with permission and endorsement from the National Comprehensive Cancer Network. To view the most recent and complete version of this or any other guideline, visit www.nccn.org. 多发性骨髓瘤 进一步治疗 疾病进展e 挽救治疗 f(临床试验或非临床试验) 或 供者淋巴细胞输注 e见多发性骨髓瘤疗效标准(MYEL-C)。 f见骨髓瘤的治疗(MYEL-D)。 i异基因干细胞移植可包括自体干细胞移植后进行的非清髓性异基因干细胞移植(小移植)或临床试验中的清髓性异基因干细胞移植(临床试验以外为3类共识)。目前数据不支持单独应用异基因小移植。 活动性(有症状 性)骨髓瘤 异基因干细胞移植后: 缓解或疾病稳定e 观察或维持治疗f 疾病进展e 自体干细胞移植后: 疾病进展e 缓解或疾病稳定e 维持治疗f 或 第二次移植 或 观察 疾病进展e 挽救治疗f(临床试验或非临床试验) 或 临床试验中异基因干细胞移植i(相对于临床试验, 常规移植为3类推荐) 挽救治疗f(临床试验或非临床试验) 或 临床试验中异基因干细胞移植i 或 临床试验中再次自体干细胞移植(2B类) MYEL-5 © National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. The Chinese edition 2011 is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. Translated and adapted with permission and endorsement from the National Comprehensive Cancer Network. To view the most recent and complete version of this or any other guideline, visit www.nccn.org. 多发性骨髓瘤 e见多发性骨髓瘤疗效标准(MYEL-C)。 f见骨髓瘤的治疗(MYEL-D)。 i异基因干细胞移植可包括自体干细胞移植后进行的非清髓性异基因干细胞移植(小移植)或临床试验中的清髓性异基因干细胞移植(临床试验以外为3类共识)。目前数据不支持单独应用异基因小移植。 j自体干细胞移植:1类证据支持诱导治疗后直接进行大剂量治疗及干细胞移植,而非将干细胞移植留待挽救治疗阶段。证据提示,尽管早期移植能够延长无进展生存期,但总生存期并无差异。 Fermand JP, Katsahian S, Divine M, et al. High dose therapy and autologous blood stem cell transplantation compared with conventional treatment in myeloma patients aged 55 to 65 years: Long term results of a randomized control trial from the Group Myelome-Autogreffe. J Clin Oncol 2005;23:9227-9233. Barlogie B, Kyle RA, Anderson KC, et al. Standard chemotherapy compared with high-dose chemoradiotherapy for multiple myeloma: final results of phase III US Intergroup Trial S9321. J Clin Oncol. 2006;24:929-936. 活动性(有症状 性)骨髓瘤 进一步治疗 复发e或进展 适合移植j 不适合移植 自体干细胞 移植(1类) 疾病进展e 挽救治疗f(临床试验或非临床试验) 或 再次自体干细胞移植(临床试验或非临床试验) 或 临床试验中异基因干细胞移植i 挽救治疗f(临床试 验或非临床试验) 姑息治疗 (见NCCN姑息治疗指南) MYEL-6 诱导治疗后: © National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. The Chinese edition 2011 is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. Translated and adapted with permission and endorsement from the National Comprehensive Cancer Network. To view the most recent and complete version of this or any other guideline, visit www.nccn.org. 多发性骨髓瘤 多发性骨髓瘤分期系统 分期 I期 II期 III期 亚组标准 A 肾功能正常(血清肌酐<2.0 mg/dL) B 肾功能异常(血清肌酐≥2.0 mg/dL) ISS标准2 血清β2微球蛋白<3.5 mg/L 血清白蛋白≥3.5 g/dL 既不符合I期又未达III期 血清β2微球蛋白≥5.5 mg/L 1Durie BG, Salmon SE. A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer 1975;36:842-854. Available at: http://www.ncbi.nlm.nih.gov/pubmed/1182674. Copyright © (1975) American Cancer Society. Reproduced with permission of John Wiley & Sons, Inc. 2Greipp PR, San Miguel J, Durie BG, et al. International staging system for multiple myeloma. J Clin Oncol 2005;23:3412-3420. Durie-Salmon标准1 符合以下全部: ● 血红蛋白>10 g/dL ● 血清钙正常或≤12 mg/dL ● 骨X线检查提示正常骨结构或仅有骨孤立性 浆细胞瘤 ● M-成分生成率低: ➤ IgG<5 g/dL ➤ IgA<3 g/dL ➤ 本周蛋白<4 g/24 h 既不符合I期又未达III期 符合下述一项或一项以上: ● 血红蛋白<8.5 g/dL ● 血清钙>12 mg/dL ● 进展性溶骨病变 ● M-成分生成率高: ➤ IgG>7 g/dL ➤ IgA>5 g/dL ➤ 本周蛋白>12 g/24 h MYEL-A © National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. The Chinese edition 2011 is the collaborative outcome of the National Comprehensive Cancer Network and Chinese key opinion leaders of the field. Translated and adapted with permission and endorsement from the National Comprehensive Cancer Network. To view the most recent and complete version of this or any other guideline, visit www.nccn.org. 多发性骨髓瘤 多发性骨髓瘤定义(冒烟型和活动性) 冒烟型(无症状性)骨髓瘤 血清M蛋白≥30 g/L 和/或 骨髓克隆性浆细胞≥10% 无相关器官或组织受损(无终末器官损害,包括骨病变)或无症状 1活动性骨髓瘤的其他表现:反复感染、继发性淀粉样变、高粘血症或低丙种球蛋白血症。 活动性(有症状性)骨髓瘤1 符合下述一项或一项以上: ● 血钙升高(>11.5 mg/dL) ● 肾功能不全(肌酐>2 mg/dL) ● 贫血(血红蛋白11.5 mg/dL或2.9 mmol/L)。 疾病进展(针对未获得CR的患者)须符合下述至少一项: ● 血清M蛋白水平升高>25%,且升高的绝对值必须≥5 g/L,至少重复检查一次以确定。 ● 24小时尿轻链增加>25%,且增加的绝对值必须≥200 mg/24 h,至少重复检查一次以确定。 ● 骨髓穿刺涂片或骨髓活检切片检查浆细胞比例增长>25%,且增加的绝对值至少≥10%。 ● 现存骨病变或软组织浆细胞瘤增大。 ● 出现新的溶骨性病变或软组织浆细胞瘤(发生压缩性骨折并不排除持续缓解,可能不表明疾病进展)。 ● 排除其他原因引起的高钙血症(校正后血钙>11.5 mg/dL或2.8 mmol/L)。 Reproduced with permission from Blade J, Samson D, Reece D, et al. Criteria for evaluating disease response
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