Garfall Alfred L, Banerjee Rahul, Frenzel Laurent, Khandanpour Cyrus, Lin Yi, Ottoni Erica, Rifkin Robert, Rockwell Sarah, Rodriguez Cesar, Villefort Humberto, Zamagni Elena
University of Pennsylvania, Philadelphia, PA, United States.
Fred Hutchinson Cancer Center, Seattle, WA, United States.
Front Oncol. 2025 Jul 30;15:1630146. doi: 10.3389/fonc.2025.1630146. eCollection 2025.
INTRODUCTION: Bispecific antibodies (BsAbs) are novel immunotherapy agents for the treatment of relapsed/refractory multiple myeloma (RRMM). Currently, 3 BsAbs (teclistamab, talquetamab, and elranatamab) are approved for the treatment of RRMM. Administering BsAbs in different practice settings is crucial to improving treatment access and patient outcomes. This report provides actionable guidance to implement safe and effective administration of BsAbs for patients with RRMM in outpatient and community settings. METHODS: Three clinician advisory workshops were held in the United States, Europe, and Latin America to discuss key factors to operationalize BsAb use in outpatient and community settings, focusing on the critical phases of practice setup, treatment initiation, and ongoing management. RESULTS: BsAb administration in outpatient and community settings requires careful planning, a well-prepared multidisciplinary team (MDT) of healthcare professionals, and clear protocols, including MDT composition, roles/responsibilities, capacity planning, patient selection criteria, step-up dosing procedure, admission processes, patient/caregiver education requirements, and adverse event (AE) monitoring/management. Comprehensive MDT training on protocols and preparedness to manage AEs is essential. Patients initiating outpatient BsAb therapy should have a reliable caregiver, access to a hospital, controlled comorbidities, and no active infections. Ensuring patients and caregivers understand the benefits, risks, and expectations of BsAb therapy is vital for successful treatment and a positive patient experience. CONCLUSION: Administering BsAbs in outpatient and community settings can be done safely and effectively with appropriate planning and protocols. Enabling safe and effective BsAb administration in these settings is essential to ensure more patients with RRMM have access to treatment and improved outcomes.
引言:双特异性抗体(BsAbs)是用于治疗复发/难治性多发性骨髓瘤(RRMM)的新型免疫治疗药物。目前,有3种双特异性抗体(替雷利珠单抗、talquetamab和elranatamab)被批准用于治疗RRMM。在不同的临床环境中使用双特异性抗体对于改善治疗可及性和患者预后至关重要。本报告提供了可操作的指导意见,以在门诊和社区环境中为RRMM患者安全有效地使用双特异性抗体。 方法:在美国、欧洲和拉丁美洲举办了3次临床医生咨询研讨会,讨论在门诊和社区环境中实施双特异性抗体使用的关键因素,重点关注实践设置、治疗启动和持续管理的关键阶段。 结果:在门诊和社区环境中使用双特异性抗体需要精心规划、由医疗保健专业人员组成的准备充分的多学科团队(MDT)以及明确的方案,包括MDT组成、角色/职责、能力规划、患者选择标准、逐步给药程序、入院流程、患者/护理人员教育要求以及不良事件(AE)监测/管理。对MDT进行关于方案和管理AE准备情况的全面培训至关重要。开始门诊双特异性抗体治疗的患者应拥有可靠的护理人员、能够前往医院、合并症得到控制且无活动性感染。确保患者和护理人员了解双特异性抗体治疗的益处、风险和期望对于成功治疗和积极的患者体验至关重要。 结论:通过适当的规划和方案,在门诊和社区环境中使用双特异性抗体可以安全有效地进行。在这些环境中实现双特异性抗体的安全有效使用对于确保更多RRMM患者能够获得治疗并改善预后至关重要。
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