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一项全国性临床试验中通过当地细胞遗传学实验室开展的新诊断多发性骨髓瘤风险适应性治疗:英国骨髓瘤研究与注册协会(UKMRA)雷达研究

Risk adapted therapy for newly diagnosed multiple myeloma delivered through local cytogenetic laboratories in a National Clinical Trial: UKMRA RADAR study.

作者信息

Mehta Dipal, Cicero Robert, Chiecchio Laura, Asher Samir, Kaiser Martin, Gooding Sarah, Royle Kara-Louise, Olivier Catherine, Levinte Doina, Kennaway Charlotte, Ramasamy Karthik, Yong Kwee, Jenner Matthew

机构信息

UCL Cancer Institute University College London London London UK.

Leeds Cancer Research UK CTU University of Leeds Leeds UK.

出版信息

EJHaem. 2025 Jun 9;6(3):e1015. doi: 10.1002/jha2.1015. eCollection 2025 Jun.

Abstract

The UKMRA RADAR study is a phase II/III clinical trial for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant. It offers a risk-adapted approach with the addition of isatuximab for genetically high-risk patients, evaluated using local cytogenetics laboratories rather than centralised testing. We have observed excellent overall success rates, with > 90% patients assigned to a risk-adapted pathway following cytogenetic testing in 25 local laboratories nationwide, with clinically-relevant turnaround times allowing > 70% patients to commence isatuximab at the earliest opportunity if indicated. This paves the way for providing standard-of-care risk-adapted treatment for multiple myeloma patients in the UK.

摘要

英国骨髓瘤研究协会(UKMRA)的RADAR研究是一项针对符合自体干细胞移植条件的新诊断多发性骨髓瘤患者的II/III期临床试验。该研究采用了一种风险适应性方法,即对于基因高危患者加用isatuximab,采用当地细胞遗传学实验室评估而非集中检测。我们观察到总体成功率极佳,在全国25个当地实验室进行细胞遗传学检测后,超过90%的患者被分配至风险适应性治疗路径,临床相关的周转时间使得超过70%的患者在有指征时能够尽早开始使用isatuximab。这为在英国为多发性骨髓瘤患者提供标准护理的风险适应性治疗铺平了道路。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd0a/12172564/6fbf5c09f4d6/JHA2-6-e1015-g001.jpg

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