AbstractTreatment of relapsed/refractory multiple myeloma (RRMM) is challenging as patients exhaust all available therapies and the disease becomes refractory to standard drug classes. Here we report the final results of LocoMMotion, the first prospective study of real-world clinical practice (RWCP) in triple-class exposed (TCE) patients with RRMM, with a median follow-up of 26.4 months (range, 0.1–35.0).

摘要复发/难治性多发性骨髓瘤（RRMM）的治疗具有挑战性，因为患者用尽了所有可用的治疗方法，并且该疾病对标准药物类别变得难治。在这里，我们报告了LocoMMotion的最终结果，LocoMMotion是第一项针对RRMM三级暴露（TCE）患者的现实世界临床实践（RWCP）的前瞻性研究，中位随访时间为26.4个月（范围0.1-35.0）。

Patients (N  =  248) had received median 4 prior LOT (range, 2–13) at enrollment. 91 unique regimens were used in index LOT. Overall response rate was 31.9% (95% CI, 26.1–38.0), median progression-free survival (PFS) was 4.6 months (95% CI, 3.9–5.6) and median overall survival was 13.8 months (95% CI, 10.8–17.0).

患者（N=248）在入组时接受了中位数为4的前批次（范围2-13）。索引批次中使用了91种独特的方案。总有效率为31.9%（95%CI，26.1-38.0），中位无进展生存期（PFS）为4.6个月（95%CI，3.9-5.6），中位总生存期为13.8个月（95%CI，10.8-17.0）。

152 patients (61.3%) had subsequent LOTs with 134 unique regimens, of which 78 were used in first subsequent LOT. Median PFS2 (from start of study through first subsequent LOT) was 10.8 months (95% CI, 8.4–13.0). 158 patients died on study, 67.7% due to progressive disease. Additional subgroup analyses and long-term safety summaries are reported.

152名患者（61.3%）随后进行了134种独特方案的批次，其中78种用于随后的第一批。中位PFS2（从研究开始到随后的第一批）为10.8个月（95%CI，8.4-13.0）。158名患者在研究中死亡，67.7%是由于进行性疾病。报告了额外的亚组分析和长期安全性总结。

The high number of RWCP treatment regimens utilized and poor clinical outcomes confirm a lack of standardized treatment for TCE patients with RRMM, highlighting the need for new treatments with novel mechanisms..

。。

IntroductionWith recent advances in multiple myeloma (MM) treatment, patients with MM are living longer [1,2,3]. However, because most patients relapse and/or their disease becomes refractory to treatment [4, 5], they cycle through standard drug classes, including proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), anti-CD38 monoclonal antibodies, and others.

引言随着多发性骨髓瘤（MM）治疗的最新进展，MM患者的寿命更长[1,2,3]。然而，由于大多数患者复发和/或其疾病变得难以治疗[4，5]，他们循环使用标准药物类别，包括蛋白酶体抑制剂（PI），免疫调节药物（IMiDs），抗CD38单克隆抗体等。

Despite a wide array of conventional treatment options for relapse/refractory MM (RRMM), periods of remission are generally short in real-world clinical practice (RWCP) [6] and outcomes worsen with each subsequent line of therapy (LOT) [5, 6], making treatment selection progressively more challenging [4, 5, 7].LocoMMotion (ClinicalTrials.gov identifier: NCT04035226) was the first multinational, prospective, observational study to examine effectiveness and safety of RWCP therapies in triple-class exposed patients with MM.

尽管复发/难治性MM（RRMM）有多种常规治疗选择，但在现实世界的临床实践（RWCP）中，缓解期通常很短，并且随后的每一种治疗方案（LOT）的结果都会恶化[5，6]，使治疗选择越来越具挑战性[4，5，7]。LocoMMotion（ClinicalTrials.gov标识符：NCT04035226）是第一项跨国，前瞻性，观察性研究，用于检查RWCP治疗在三级暴露MM患者中的有效性和安全性。

Its prospective study design allowed for collection of patient-level baseline characteristics and outcome parameters that are not commonly collected during routine clinical practice. Previous results from LocoMMotion, reported at 16.1 months median study follow-up, showed a lack of clear standard of care for treatment of triple-class exposed patients and poor outcomes [8].

其前瞻性研究设计允许收集常规临床实践中不常收集的患者水平基线特征和结果参数。LocoMMotion之前的结果在16.1个月的中位研究随访中报告，显示缺乏明确的三级暴露患者治疗标准和不良结局（8）。

Ninety-one unique regimens were used in the index LOT (first treatment after enrollment), and the overall response rate (ORR) was 31.5%, with median progression-free survival (PFS) and overall survival (OS) of 4.6 months and 13.8 months, respectively. Treatment-emergent adverse events (TEAEs) were reported in 85.9% of patients, with 56.5% reporting grade 3/4 TEAEs.

指数批次（入组后第一次治疗）使用了91种独特的方案，总有效率（ORR）为31.5%，中位无进展生存期（PFS）和总生存期（OS）分别为4.6个月和13.8个月。85.9%的患者报告了治疗紧急不良事件（TEAE），其中56.5%报告了3/4级TEAE。

Here, we report results from the final analysis of LocoMMotion, including mature survival data, additional subgroup analyses, subsequent therapies, and their .

。

Data availability

数据可用性

Although these data are not currently publicly available for sharing, requests for sharing can be sent to the Corresponding Author and will be evaluated on an individual basis.

虽然这些数据目前尚未公开共享，但共享请求可以发送给相应的作者，并将根据个人情况进行评估。

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2024https://www.ema.europa.eu/en/documents/product-information/carvykti-epar-product-information_en.pdf.Janssen生物技术公司：TECVAYLI®（teclistamab）产品特性总结。2024https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf.Download参考文献致谢本研究（ClinicalTrials.gov标识符：NCT04035226）由Janssen Research＆Development，LLC和Legend Biotech USA Inc.资助。

Medical writing support was provided by Andrew Marson and Sarika Pathak Sharma, PhD, of Eloquent Scientific Solutions, and funded by Janssen Global Services, LLC. The authors thank the LocoMMotion study team, including Jonathan Squire, Kensa Hatch, Lorenzo Acciarri, Henrieke Bruin, and Jeannie Kearl.Author informationAuthors and AffiliationsHospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBASL), Centro.

医学写作支持由Eloquent Scientific Solutions的Andrew Marson和Sarika Pathak Sharma博士提供，并由Janssen Global Services，LLC资助。作者感谢LocoMMotion研究团队，包括Jonathan Squire，Kensa Hatch，Lorenzo Acciarri，Henrieke Bruin和Jeannie Kearl。作者信息作者和附属机构萨拉曼卡国立大学，萨拉曼卡生物医学研究所（IBASL），Centro。

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María-Victoria Mateos.Ethics declarations

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Competing interests

相互竞争的利益

M-VM has received honoraria from or served on the board of directors/advisory committees for AbbVie, Adaptive Biotechnologies, Amgen, BMS/Celgene, GSK, Janssen, Oncopeptides, Pfizer, Regeneron, Roche, Sanofi, Seagen, and Takeda. KW has served as a consultant and received honoraria from Adaptive Biotechnologies, Karyopharm, and Takeda; has received honoraria from Roche; and has received honoraria and served as a member on boards of directors and/or advisory committees for Amgen, BMS, Celgene, GSK, Janssen, Oncopeptides, and Sanofi.

。KW曾担任顾问，并获得了Adaptive Biotechnologies，Karyopharm和武田的酬金；已获得罗氏公司的酬金；并获得酬金，并担任安进（Amgen）、BMS、Celgene、GSK、詹森（Janssen）、Oncopeptides和赛诺菲（Sanofi）的董事会和/或咨询委员会成员。

VDS has served on an advisory board or speakers’ bureaus and received honoraria from AbbVie, Alexion, AOP Health, argenx, BMS, GSK, Grifols, Leo Pharma, Novartis, Novo Nordisk, Sanofi, SOBI, and Takeda. HG has served as a consultant for Amgen, Novartis, and Takeda; has served as a consultant and received honoraria, grants, and/or provision of investigational medicinal product and research funding from Amgen, BMS, Celgene, Chugai, Janssen, and Sanofi; has received research funding from Incyte, Molecular Partners, MSD, Mundipharma, and Novartis; and has received other grants from Dietmer Hopp Foundation.

VDS曾在咨询委员会或发言人办公室任职，并获得了艾伯维（AbbVie）、亚力兄（Alexion）、AOP Health、阿根克斯（argenx）、BMS、葛兰素史克（GSK）、格里弗斯（Grifols）、利奥制药（Leo Pharma）、诺华（Novartis）、诺和诺德（Novo Nordisk）、赛诺菲（Sanofi）、索比（SOBI）和武田（Takeda）的酬金。；曾担任顾问，并从安进（Amgen），BMS，Celgene，Chugai，Janssen和赛诺菲（Sanofi）获得酬金，赠款和/或提供研究药物和研究资金；已获得Incyte，Molecular Partners，MSD，Mundipharma和诺华的研究资助；并获得了迪特默·霍普基金会的其他资助。

MD has received honoraria from Amgen, BMS, GSK, and Janssen; and has served on the speakers’ bureau for Janssen. MM has received honoraria from Adaptive Biotech, Amgen, Astellas, BMS, Gilead, Novartis, Pfizer, and Takeda; and has received honoraria/research funding from Celgene and Sanofi. JL-H has no relationships to disclose.

MD已获得安进，BMS，GSK和杨森的酬金；曾在杨森演讲局任职。MM获得了Adaptive Biotech，Amgen，Astellas，BMS，Gilead，Novartis，Pfizer和武田的酬金；并获得了Celgene和赛诺菲的荣誉/研究资助。JL-H没有关系要披露。

DD is an employee/consultant/honoraria/member of board of directors/advisory committees for Janssen Cilag; and a member of the board of directors/advisory committees/received research funding from Celgene. EA has no relationships to disclose. LV has served on the advisory board of BMS, Janssen, and Takeda.

；董事会/咨询委员会的一名成员/获得了Celgene的研究资助。EA没有关系要披露。LV曾担任BMS，Janssen和Takeda的顾问委员会成员。

AP has received.

AP已收到。

Additional informationPublisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.Supplementary informationTable S1: Ethics committees/Institutional Review Boards in LocoMMotionTable S2: Regimens received by ≥3 patient in any given LOT.Table S3: TEAEs reported in ≥5% of patients in index LOT.Figure S1: Forest plot of subgroup analyses of progression-free survival and overall survival by RRC.Rights and permissions.

Additional informationPublisher的注释Springer Nature在已发布的地图和机构隶属关系中的管辖权主张方面保持中立。补充信息表S1：当地伦理委员会/机构审查委员会表S2：任何给定批次中≥3名患者接受的方案。表S3：指数批次中≥5%的患者报告了TEAE。图S1:RRC对无进展生存期和总生存期的亚组分析的森林图。权限和权限。

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Reprints and permissionsAbout this articleCite this articleMateos, MV., Weisel, K., De Stefano, V. et al. LocoMMotion: a study of real-life current standards of care in triple-class exposed patients with relapsed/refractory multiple myeloma – 2-year follow-up (final analysis).

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Leukemia (2024). https://doi.org/10.1038/s41375-024-02404-6Download citationReceived: 04 January 2024Revised: 28 June 2024Accepted: 30 August 2024Published: 25 September 2024DOI: https://doi.org/10.1038/s41375-024-02404-6Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

白血病（2024）。https://doi.org/10.1038/s41375-024-02404-6Download引文收到日期：2024年1月4日修订日期：2024年6月28日接受日期：2024年8月30日发布日期：2024年9月25日OI：https://doi.org/10.1038/s41375-024-02404-6Share本文与您共享以下链接的任何人都可以阅读此内容：获取可共享链接对不起，本文目前没有可共享的链接。。

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