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来自汇总的LocoMMotion和MoMMent研究的三药联合暴露的复发/难治性多发性骨髓瘤患者髓外疾病的结局

Outcomes of Patients With Extramedullary Disease in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma From the Pooled LocoMMotion and MoMMent Studies.

作者信息

Moreau Philippe, Mateos María-Victoria, Goldschmidt Hartmut, Garcia Maria Esther Gonzalez, Besemer Britta, Perez Marta Sonia Gonzalez, Mohty Mohamad, Lindsey-Hill Joanne, Kirkpatrick Suriya, Delforge Michel, Angelucci Emanuele, Raimondo Francesco Di, Vij Ravi, Doyle Margaret, Gray Kathleen, Albrecht Claire, Strulev Vadim, Haddad Imène, Koskinen Silva, Acciarri Lorenzo, Buyze Jozefien, Weisel Katja

机构信息

Department of Hematology, University Hospital Hotel-Dieu, Nantes, France.

Department of Hematology, University Hospital of Salamanca/IBSAL/CIC/CIBERONC, Salamanca, Spain.

出版信息

Clin Lymphoma Myeloma Leuk. 2025 Sep;25(9):646-655.e1. doi: 10.1016/j.clml.2025.03.014. Epub 2025 Mar 27.

Abstract

BACKGROUND

Patients with relapsed/refractory multiple myeloma (RRMM) who develop extramedullary disease (EMD) generally have a poor prognosis, highlighting the urgent need for new therapies. We report effectiveness outcomes and safety in patients with and without EMD from the pooled analysis of LocoMMotion and MoMMent.

METHODS

LocoMMotion and MoMMent-1 are prospective, noninterventional, consecutive studies assessing the evolving standard of care from 20192022 in patients with triple-class exposed RRMM.

RESULTS

Of 302 patients, 29 had EMD per investigator discretion and only 15 patients were assessed as having true extramedullary plasmacytoma (EMP; defined as patients with ≥1 EMP lesion) by the response review committee. The 29 EMD patients received 21 unique regimens (most commonly chemotherapy-based regimens). Of the 29 patients with EMD, overall response rate (ORR) was 24.1%, median progression-free survival (PFS) was 2.66 months, median overall survival (OS) was 7.16 months, and median time to next treatment (TTNT) was 3.09 months. All responses were lower (ORR) and shorter (median PFS, OS, and TTNT) in patients with EMD vs patients without EMD. Nineteen (65.5%) patients with EMD received ≥1 subsequent lines of therapy. Of those, two (10.5%) patients received bispecific antibodies and achieved a partial response or better; three (15.8%) patients received antibody-drug conjugates (responses were unknown or not determined at data cut-off), and no patients received chimeric antigen receptorT cell therapy.

CONCLUSIONS

These results demonstrate the urgent need for more effective novel therapies for patients with EMD and highlight the need to use clear definitions of EMD and EMD response criteria for clinical trials.

摘要

背景

复发/难治性多发性骨髓瘤(RRMM)患者若发生髓外疾病(EMD),通常预后较差,这凸显了对新疗法的迫切需求。我们通过对LocoMMotion和MoMMent研究的汇总分析,报告了有和没有EMD的患者的疗效结果及安全性。

方法

LocoMMotion和MoMMent-1是前瞻性、非干预性、连续性研究,评估了2019年至2022年三重暴露RRMM患者不断变化的治疗标准。

结果

在302例患者中,根据研究者判断,29例有EMD,而反应评估委员会仅将15例患者评估为患有真正的髓外浆细胞瘤(EMP;定义为有≥1个EMP病灶的患者)。这29例EMD患者接受了21种不同的治疗方案(最常见的是以化疗为基础的方案)。在29例EMD患者中,总缓解率(ORR)为24.1%,中位无进展生存期(PFS)为2.66个月,中位总生存期(OS)为7.16个月,中位下次治疗时间(TTNT)为3.09个月。与没有EMD的患者相比,EMD患者的所有缓解率(ORR)更低,缓解持续时间(中位PFS、OS和TTNT)更短。19例(65.5%)EMD患者接受了≥1线后续治疗。其中,2例(10.5%)患者接受双特异性抗体治疗并获得部分缓解或更好的疗效;3例(15.8%)患者接受抗体药物偶联物治疗(在数据截止时反应未知或未确定),没有患者接受嵌合抗原受体T细胞疗法。

结论

这些结果表明,迫切需要为EMD患者提供更有效的新疗法,并强调在临床试验中需要使用明确的EMD定义和EMD反应标准。

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