Popat Rakesh, Basu Supratik, Henshaw Sarah, Karunanithi Kamaraj, Ramasamy Karthik, Singh Inderjit, Tailor Anish, Walker Ian, Warren Tim, Ali Noreen, Duffield Charles, Cook Gordon
Haematology University College London Hospitals NHS Foundation Trust London UK.
University of Wolverhampton The Royal Wolverhampton NHS Trust Wolverhampton UK.
EJHaem. 2024 Oct 25;5(6):1133-1143. doi: 10.1002/jha2.1038. eCollection 2024 Dec.
Multiple myeloma (MM) is a relapsing, debilitating blood cancer which remains incurable despite advances in treatments. Patients typically receive multiple lines of treatment, to which they become refractory, thereby limiting treatment options. B-cell maturation antigen (BCMA) bispecific antibodies (BsAbs) represent a novel modality of treatment that has significant efficacy for relapsed or refractory patients.The objective was to develop consensus statements for the effective implementation of BCMA BsAbs for relapsed or refractory MM patients within the National Health Service (NHS).
The process employed a modified Delphi methodology. In March 2023, a literature review on the topic of novel treatments for MM was performed using the PubMed database.The process employed a modified Delphi methodology. Following a literature review, a steering group of eight expert clinicians identified and agreed on five main topics of focus and 44 statements. These were then developed into an online survey which was distributed to healthcare professionals working in Levels 1, 2 and 3 haematology centres in the United Kingdom. Results were then shared with the expert panel to determine conclusions. The threshold for consensus agreement was set at 75%.
A total of 60 responses were received from all three centre levels. There was representation from all targeted centres. Consensus was achieved in 42 statements (95%) across three broad areas: the patient profile, initiation and step-up dosing, monitoring and ongoing care, the role of multidisciplinary team and service designs for optimal management, consensus was not achieved for two statements. Given the level of agreement and that the stopping criteria were met, it was decided not to undertake further Delphi rounds.
This consensus provides a framework to support the effective introduction of novel treatments for MM in the NHS. The results were used to inform a checklist for use within haematology services when considering the provision of MM care specific to BCMA BsAbs.
多发性骨髓瘤(MM)是一种复发性、使人衰弱的血液癌症,尽管治疗取得了进展,但仍然无法治愈。患者通常接受多线治疗,但会对这些治疗产生耐药性,从而限制了治疗选择。B细胞成熟抗原(BCMA)双特异性抗体(BsAb)代表了一种新型治疗方式,对复发或难治性患者具有显著疗效。目的是制定共识声明,以在国民健康服务体系(NHS)内有效实施针对复发或难治性MM患者的BCMA BsAb治疗。
该过程采用了改良的德尔菲法。2023年3月,使用PubMed数据库对MM新型治疗主题进行了文献综述。该过程采用了改良的德尔菲法。在文献综述之后,一个由八名专家临床医生组成的指导小组确定并商定了五个主要关注主题和44条声明。然后将这些内容编制成在线调查问卷,分发给在英国1级、2级和3级血液学中心工作的医疗专业人员。然后将结果与专家小组分享以确定结论。共识达成的阈值设定为75%。
从所有三个中心级别共收到60份回复。所有目标中心均有代表参与。在三个广泛领域的42条声明(95%)中达成了共识:患者概况、起始和递增剂量、监测与持续护理、多学科团队的作用以及优化管理的服务设计,有两条声明未达成共识。鉴于达成的一致程度以及满足停止标准,决定不再进行进一步的德尔菲轮次。
这一共识提供了一个框架,以支持在NHS中有效引入MM的新型治疗方法。这些结果被用于制定一份检查表,供血液学服务机构在考虑提供针对BCMA BsAb的MM护理时使用。