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复发/难治性多发性骨髓瘤患者中玛格罗利单抗联合用药的2期多臂研究最终结果

Final Results of a Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma.

作者信息

Paul Barry, Minarik Jiri, Cottini Francesca, Gasparetto Cristina, Khouri Jack, Gandhi Mitul, Hillengass Jens, Levy Moshe, Liedtke Michaela, Manda Sudhir, Sandhu Irwindeep, Sborov Douglas, Spicka Ivan, Usmani Saad, Dong Mei, Gu Lin, Leung Carmen, Doshi Parul, Chen Christine, Pour Ludek

机构信息

Atrium Health Levine Cancer Institute Wake Forest University School of Medicine Charlotte North Carolina USA.

Fakultni Nemocnice Olomouc Olomouc Czech Republic.

出版信息

EJHaem. 2025 Jun 6;6(3):e70072. doi: 10.1002/jha2.70072. eCollection 2025 Jun.

Abstract

INTRODUCTION

Patients with pretreated relapsed/refractory multiple myeloma (RRMM) have a poor prognosis and limited treatment options, underscoring the need for safe treatments with durable efficacy.

METHODS

This Phase 2 study evaluated magrolimab (Magro) plus daratumumab (Dara) or pomalidomide/dexamethasone (Pd) or carfilzomib/dexamethasone (Kd) in RRMM. The primary efficacy endpoint was objective response rate (ORR).

RESULTS

ORR was 14.3% (Magro+Dara; = 14), 20.0% (Magro+Pd; = 10) and 36.4% (Magro+Kd; = 11). There were two dose-limiting toxicities: febrile neutropenia (Magro+Dara) and infusion-related reaction (Magro+Pd). Grade ≥ 3 Magro-related adverse event (AE) rates were 64.3% (Magro+Dara), 60.0% (Magro+Pd) and 63.6% (Magro+Kd). Two deaths were AE-related; neither was Magro related.

CONCLUSION

As the study closed early, insights into the clinical profile of Magro combinations in RRMM are limited.

TRIAL REGISTRATION

This trial was registered at www.clinicaltrials.gov as #NCT04892446.

摘要

引言

先前接受过治疗的复发/难治性多发性骨髓瘤(RRMM)患者预后较差且治疗选择有限,这凸显了对具有持久疗效的安全治疗方法的需求。

方法

这项2期研究评估了马格罗利单抗(Magro)联合达雷妥尤单抗(Dara)或泊马度胺/地塞米松(Pd)或卡非佐米/地塞米松(Kd)用于RRMM的疗效。主要疗效终点为客观缓解率(ORR)。

结果

ORR分别为14.3%(Magro+Dara;n = 14)、20.

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