MULTIPLE MYELOMA

多发性骨髓瘤
  • 文章类型: Journal Article
    我们为适应症提供更新的指导和标准,收购,[18F]FDGPET/CT对浆细胞疾病的解释。报告了程序和特征,并讨论了[18F]FDGPET/CT临床使用的不同方案。该文件为临床医生和技术人员提供了最佳的可用证据,以支持在常规实践和未来研究中实施[18F]FDGPET/CT成像。
    We provide updated guidance and standards for the indication, acquisition, and interpretation of [18F]FDG PET/CT for plasma cell disorders. Procedures and characteristics are reported and different scenarios for the clinical use of [18F]FDG PET/CT are discussed. This document provides clinicians and technicians with the best available evidence to support the implementation of [18F]FDG PET/CT imaging in routine practice and future research.
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  • 文章类型: Journal Article
    许多研究记录了种族,社会经济,地理,美国(US)多发性骨髓瘤患者在诊断和一线管理方面的其他差异。相比之下,尽管存在大量新的治疗选择,但对于复发/难治性多发性骨髓瘤(RRMM)的治疗差异知之甚少.在这次审查中,我们讨论了RRMM中差异的表现形式以及减轻其影响的策略。免疫调节药物可以在许多轴上产生差异,例如,对于社会经济脆弱的患者,由于Duffy-null状态以及后勤障碍造成的时间毒性和经济毒性而导致的不适当的低剂量。鉴于在试验中如何规定卡非佐米和地塞米松等药物与在现实世界实践中如何优化以降低毒性之间的脱节,因此在高容量中心获得骨髓瘤专业知识是一个关键的考虑因素。嵌合抗原受体T细胞疗法和双特异性抗体疗法的差异跨越种族,民族,和社会经济线在很大程度上是由于它们在高容量中心之外的可用性有限。差异的另一个阴险来源是RRMM中的支持性护理,从黑人患者的疼痛控制不足到农村地区初级保健提供者的有限。我们讨论了旨在减轻这些差异的几种解决方案的基本原理和证据基础:例如,(1)与社区肿瘤学家的双向共同管理,(2)根据健康的社会决定因素筛查危险因素,(3)在临床试验方面建立患者信任的策略,和(4)纵向接触初级保健提供者。随着RRMM的治疗前景不断扩大,这些领域的努力将有助于确保所有美国患者都能平等地获得和穿越这一景观。
    Many studies have documented racial, socioeconomic, geographic, and other disparities for United States (US) patients with multiple myeloma pertaining to diagnosis and frontline management. In contrast, very little is known about disparities in the management of relapsed/refractory multiple myeloma (RRMM) despite a plethora of novel treatment options. In this review, we discuss the manifestations of disparities in RRMM and strategies to mitigate their impact. Immunomodulatory drugs can create disparities on many axes, for example inappropriately low dosing due to Duffy-null status as well as time toxicity and financial toxicity from logistical hurdles for socioeconomically vulnerable patients. Access to myeloma expertise at high-volume centers is a critical consideration given the disconnect between how drugs like carfilzomib and dexamethasone are prescribed in trials versus optimized in real-world practice to lower toxicities. Disparities in chimeric antigen receptor T-cell therapy and bispecific antibody therapy span across racial, ethnic, and socioeconomic lines in large part due to their limited availability outside of high-volume centers. Another insidious source of disparities is supportive care in RRMM, ranging from inadequate pain control in Black patients to limited primary care provider access in rural settings. We discuss the rationales and evidence base for several solutions aimed at mitigating these disparities: for example, (1) bidirectional co-management with community-based oncologists, (2) screening for risk factors based on social determinants of health, (3) strategies to build patient trust with regard to clinical trials, and (4) longitudinal access to a primary care provider. As the treatment landscape for RRMM continues to expand, these types of efforts by the field will help ensure that this landscape is equally accessible and traversable for all US patients.
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  • 文章类型: English Abstract
    Multiple myeloma (MM) is the second most common hematologic malignant tumor. Standard holistic treatment model and new drug-based regimens have greatly improved the survival of patients with MM; however, minimal residual disease (MRD) causes relapse in most patients. Therefore, combining MRD testing on the basis of traditional serological efficacy evaluation is necessary to achieve a more accurate assessment of the patient\'s disease status. At present, next-generation flow cytometry (NGF) and next-generation sequencing (NGS) are the mainstream technologies for detecting MRD based on bone marrow samples. To standardize and normalize MRD detection, the expert group discussed and formulated Chinese expert consensus on the application of NGF and NGS technology for bone marrow MRD detection in patients with MM.
    多发性骨髓瘤(MM)是血液系统第二大常见恶性肿瘤,标准的整体治疗模式及以新药为主的方案极大地改善了MM患者的生存,但微小残留病(MRD)导致大多数患者复发。因此,需要在传统血清学疗效评估的基础上联合MRD检测,以更精准地评估患者的疾病状态。目前,二代流式细胞术(NGF)和二代测序(NGS)是基于骨髓样本检测MRD的主流技术。为使MRD检测标准化和规范化,专家组讨论制订了在MM患者中应用NGF和NGS技术进行骨髓MRD检测的中国专家共识。.
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  • 文章类型: Journal Article
    承认在肿瘤环境中越来越多地使用全身磁共振成像(WB-MRI),我们进行了叙述性审查,重点关注考试的实践方面,并提供了文献中描述的各种采集方案的综合.首先,我们谈到了病人准备的话题,强调提高考试接受度的方法。这包括减少焦虑和患者痛苦的策略,改善员工与患者的互动,增加患者的整体舒适度。其次,我们分析了现有成像指南中推荐的WB-MRI采集协议,例如MET-RADS-P,MY-RADS,和ONCO-RADS,并提供了有关WB-MRI在肿瘤学中的其他扩展应用的文献中报道的采集协议的概述,在乳腺癌患者中,卵巢癌,黑色素瘤,结直肠癌和肺癌,淋巴瘤和未知的原发性癌症。最后,我们建议了来自三个不同供应商的MR系统中可能的全身图像采集参数.
    Acknowledging the increasing use of whole-body magnetic resonance imaging (WB-MRI) in the oncological setting, we conducted a narrative review focusing on practical aspects of the examination and providing a synthesis of various acquisition protocols described in the literature. Firstly, we addressed the topic of patient preparation, emphasizing methods to enhance examination acceptance. This included strategies for reducing anxiety and patient distress, improving staff-patient interactions, and increasing overall patient comfort. Secondly, we analysed WB-MRI acquisition protocols recommended in existing imaging guidelines, such as MET-RADS-P, MY-RADS, and ONCO-RADS, and provided an overview of acquisition protocols reported in the literature regarding other expanding applications of WB-MRI in oncology, in patients with breast cancer, ovarian cancer, melanoma, colorectal and lung cancer, lymphoma, and cancers of unknown primary. Finally, we suggested possible acquisition parameters for whole-body images across MR systems from three different vendors.
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  • 文章类型: English Abstract
    High-risk multiple myeloma (HRMM) refers to patients with multiple myeloma whose overall survival time is less than 2-3 years under current standardized diagnosis and treatment. By combining various static and dynamic prognostic factors, risk stratification is performed to identify HRMM patients early and treat patients with personalized strategies, with the aim of significantly improving adverse survival outcomes in HRMM patients. Although the clinical value of HRMM has reached a consensus domestically in recent years, there still exist confusions and ambiguities in the definition, high-risk factors, risk stratification, and treatment of HRMM, necessitating standardization. In order to enhance the diagnostic and treatment capabilities of Chinese physicians in HRMM, the Professional Committee of Hematologic Malignancies of the Chinese Anti-Cancer Association (CACA) and the Multiple Myeloma Expert Committee of the Chinese Society of Clinical Oncology (CSCO) have organized relevant experts to develop this consensus. This consensus aims to clarify the definition of HRMM, high-risk factors, and risk stratification system, and provide treatment recommendations for HRMM, thereby improving the quality of life and prognosis of Chinese HRMM patients.
    高危多发性骨髓瘤(High risk multiple myeloma,HRMM)是指在当前规范诊疗下,总生存期不足2~3年的骨髓瘤患者。结合多种静态和动态预后因素进行危险度分层,早期识别HRMM患者,并采用个体化风险分层治疗策略,有望显著改善HRMM患者不良生存结局。尽管近年来,国内对HRMM的临床价值已达成共识,但在HRMM的定义、高危因素、危险度分层和治疗等方面仍存在混乱和不明确之处,亟需规范。为提高中国医师对HRMM的诊治水平,中国抗癌协会血液肿瘤专业委员会和中国临床肿瘤学会多发性骨髓瘤专家委员会组织相关专家制定了本共识。该共识旨在明确HRMM的定义、高危因素和危险度分层体系,提供HRMM的治疗推荐,从而提高中国HRMM患者的生存质量和预后。.
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  • 文章类型: English Abstract
    Flow cytometry plays an important role in the diagnosis and treatment of plasma cell diseases, particularly in the detection of circulating plasma cells (CPCs) in the peripheral blood. A consensus about the normalized use of flow cytometry in detection of CPCs in peripheral blood in clinical practice has been achieved. This consensus is founded on evidence-based principles, which elucidates the timing and value of flow cytometry for the detection of CPCs in the monoclonal gammopathy of undetermined significance, smoldering myeloma, multiple myeloma, and plasma cell leukemia and standardizes flow cytometry in the detection of CPCs in plasma cell diseases.
    流式细胞术检测外周血循环浆细胞(circulating plasma cells,CPCs)在浆细胞病的诊疗中已经展示出了重要价值。为促进流式细胞术检测CPCs在临床中的规范使用,特制定本共识。本共识依据循证原则,明确了意义未明的单克隆免疫球蛋白血症、冒烟型骨髓瘤、多发性骨髓瘤和浆细胞白血病进行CPCs检测的时机与价值,并对CPCs的流式细胞术检测方法进行规范。.
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  • 文章类型: Journal Article
    嵌合抗原受体(CAR)T细胞疗法在晚期难治性多发性骨髓瘤患者中显示出希望,应答率从73%到98%不等。迄今为止,已经批准了三种产品:Idecabtagenevicleucel(ide-cel)和ciltacabtageneautoleucel(cilta-cel),由美国食品和药物管理局批准,欧洲药品管理局,加拿大卫生部(仅限IDE-cel),和巴西ANVISA(仅限cilta-cel);和equectageneautoleucel(eque-cel),这是中国国家药品监督管理局批准的。CAR-T细胞疗法不同于以前的抗骨髓瘤疗法,具有独特的毒性作用,需要不同的缓解策略。因此,来自国际骨髓瘤工作组的专家小组将为骨髓瘤中CAR-T细胞治疗的临床应用提供指导.这一共识来自造血细胞移植领域的专家,细胞疗法,和多发性骨髓瘤治疗。
    Chimeric antigen receptor (CAR) T-cell therapy has shown promise in patients with late-line refractory multiple myeloma, with response rates ranging from 73 to 98%. To date, three products have been approved: Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), which are approved by the US Food and Drug Administration, the European Medicines Agency, Health Canada (ide-cel only), and Brazil ANVISA (cilta-cel only); and equecabtagene autoleucel (eque-cel), which was approved by the Chinese National Medical Products Administration. CAR T-cell therapy is different from previous anti-myeloma therapeutics with unique toxic effects that require distinct mitigation strategies. Thus, a panel of experts from the International Myeloma Working Group was assembled to provide guidance for clinical use of CAR T-cell therapy in myeloma. This consensus opinion is from experts in the field of haematopoietic cell transplantation, cell therapy, and multiple myeloma therapeutics.
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  • 文章类型: Journal Article
    多发性骨髓瘤仍然是一种不治之症,尽管开发了许多药物类别和组合,有助于改善总体生存率。针对癌细胞表面抗原的免疫疗法,如嵌合抗原受体(CAR)T细胞疗法和T细胞重定向双特异性抗体,最近获得了监管部门的批准,并显示出前所未有的效力。然而,这些免疫疗法具有独特的作用机制和毒性,与以前的骨髓瘤治疗方法不同,因此,临床试验和早期访问计划的经验对于为患者管理提供具体建议至关重要,特别是当这些代理商在世界许多地方都可用时。这里,我们为使用双特异性抗体治疗骨髓瘤提供专家共识的临床实践指南.国际骨髓瘤工作组还参与收集接受此类免疫疗法治疗的患者的预期实时数据,目的是不断学习并调整临床实践,以优化接受免疫疗法的患者的管理。
    Multiple myeloma remains an incurable disease, despite the development of numerous drug classes and combinations that have contributed to improved overall survival. Immunotherapies directed against cancer cell-surface antigens, such as chimeric antigen receptor (CAR) T-cell therapy and T-cell-redirecting bispecific antibodies, have recently received regulatory approvals and shown unprecedented efficacy. However, these immunotherapies have unique mechanisms of action and toxicities that are different to previous treatments for myeloma, so experiences from clinical trials and early access programmes are essential for providing specific recommendations for management of patients, especially as these agents become available across many parts of the world. Here, we provide expert consensus clinical practice guidelines for the use of bispecific antibodies for the treatment of myeloma. The International Myeloma Working Group is also involved in the collection of prospective real-time data of patients treated with such immunotherapies, with the aim of learning continuously and adapting clinical practices to optimise the management of patients receiving immunotherapies.
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  • 文章类型: Journal Article
    静脉血栓栓塞(VTE)在多发性骨髓瘤的背景下提出了重大挑战,在新诊断的患者中,发病率高达10%,在复发/难治的情况下,发病率不同。准确的VTE风险评估和个性化的血栓预防策略是骨髓瘤支持治疗的重要组成部分。有三种经过验证的风险评估模型用于预测新诊断的骨髓瘤-SAVED的VTE风险。IMPEDE-VTE,PRISM。在这次审查中,我们深入研究了VTE风险预测模型在当前治疗中的实际应用.通过强调定制方法的必要性,我们强调了考虑患者特异性的重要性,疾病特异性,以及每种临床情景中特定治疗的风险因素,并使用这些数据来补充风险评估模型的输出。我们还提供了关于骨髓瘤VTE血栓预防的现有数据的摘要。并强调应强烈考虑直接口服抗凝剂的具体情况。我们的目标是通过分析特定患者病例来填补VTE预防和管理方面的关键空白,并为临床医生提供实用概述。
    Venous thromboembolism (VTE) poses a significant challenge in the context of multiple myeloma, with an incidence of up to 10% in newly diagnosed patients and varying frequency in the relapsed/refractory setting. Accurate VTE risk assessment and personalized thromboprophylaxis strategies are important parts of supportive care in myeloma. There are three validated risk assessment models for prediction of VTE risk in newly diagnosed myeloma-SAVED, IMPEDE-VTE, and PRISM. In this review, we delve into the practical applications of VTE risk prediction models in the context of current therapies. By emphasizing the necessity of a tailored approach, we underscore the importance of considering patient-specific, disease-specific, and treatment-specific risk factors in each clinical scenario, and using that data to complement the output from risk assessment models. We also provide a summary of currently available data on VTE thromboprophylaxis in myeloma, and highlight specific situations where direct oral anticoagulants should be strongly considered. Our objective is to fill the critical gaps in VTE prophylaxis and management through the analysis of specific patient cases and provide a practical overview for clinicians.
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  • 文章类型: Journal Article
    嵌合抗原受体T细胞疗法(CAR-T)彻底改变了复发性和/或难治性多发性骨髓瘤(RRMM)的管理。然而,CAR-T治疗失败并不少见,仍然是一个主要的治疗挑战。在评估和管理RRMM中的CAR-T失败后,移植和细胞治疗计划之间存在实质性差异。美国移植和细胞治疗协会(ASTCT)实践指南委员会在2023年9月至2023年12月之间进行了一项在线横断面调查,以确定骨髓瘤,移植和细胞治疗医生的监测实践模式,诊断,和管理CAR-T故障。这项调查的目的是了解临床实践模式并确定进一步调查的领域。电子邮件调查发送给1311名ASTCT医师成员,80名(6.1%)受访者完成了调查,他们确定为58%的白人,66%男性,51%的患者有超过10年的临床经验。89%的受访者隶属于大学/教学中心;56%的人有以骨髓瘤为重点的移植和/或细胞治疗实践。CAR-T后监测实验室研究通常每4周进行一次,而监测骨髓活检和/或影像学监测最常见于3个月.64%的受访者经常或总是考虑活检或影像学检查以确认复发。最受欢迎的CAR-T失败后救助方案是GPRC5D定向免疫疗法(30%),用于复发≤3个月,BCMA定向双特异性疗法(32.5%)用于复发>3个月。41%的受访者表示,CAR-T后延长的血细胞减少症“经常”或“总是”是下一线治疗的障碍;53%的受访者表示,他们提供了干细胞增强作为缓解方法。实践模式的重大跨中心差异提高了对合作研究和专家临床建议的需求,以描述CAR-T疾病监测后的最佳实践。治疗失败的最佳工作,和选择救援疗法。
    Chimeric antigen receptor T cell therapy (CAR-T) has revolutionized the management of relapsed and/or refractory multiple myeloma (RRMM). However, CAR-T treatment failure is not uncommon and remains a major therapeutic challenge. There is substantial variability across transplantation and cellular therapy programs in assessing and managing post-CAR-T failures in patients with RRMM. The American Society for Transplantation and Cellular Therapy (ASTCT) Committee on Practice Guidelines conducted an online cross-sectional survey between September 2023 and December 2023 to determine myeloma, transplantation, and cellular therapy physicians\' practice patterns for the surveillance, diagnosis, and management of CAR-T failure. The intent of this survey was to understand clinical practice patterns and identify areas for further investigation. Email surveys were sent to 1311 ASTCT physician members, of whom 80 (6.1%) completed the survey. The respondents were 58% white and 66% male, and 51% had >10 years of clinical experience. Most (89%) respondents were affiliated with a university/teaching center, and 56% had a myeloma-focused transplantation and/or cellular therapy practice. Post-CAR-T surveillance laboratory studies were commonly done every 4 weeks, and surveillance bone marrow biopsies and/or imaging surveillance were most commonly done at 3 months. Sixty-four percent of the respondents would often or always consider biopsy or imaging to confirm relapse. The most popular post-CAR-T failure rescue regimen was GPRC5D-directed immunotherapy (30%) for relapses occurring ≤3 months and BCMA-directed bispecific therapies (32.5%) for relapse at >3 months. Forty-one percent of the respondents endorsed post-CAR-T prolonged cytopenia as being \"often\" or \"always\" a barrier to next-line therapy; 53% had offered stem cell boost as a mitigation approach. Substantial across-center variation in practice patterns raises the need for collaborative studies and expert clinical recommendations to describe best practices for post-CAR-T disease surveillance, optimal workup for treatment failure, and choice of rescue therapies.
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