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引用次数: 0
摘要
临床试验主要分为两类:行业赞助的试验和研究者发起的试验。这两种试验就像汽车上的两个轮子,对治疗方法的开发至关重要。针对多发性骨髓瘤开展的临床试验不计其数,促进了新药的开发和当前治疗格局的形成。高效的新型免疫疗法已经出现,如双特异性抗体和嵌合抗原受体 T 细胞疗法,并可能在不久的将来被纳入治疗范围。然而,鉴于目前标准疗法的性能有所改善,免疫疗法的缺点(如毒性)在某些患者身上可能会大于益处(疗效)。因此,临床试验旨在根据治疗后的疗效和疾病风险等因素对治疗方法进行分层评估,分层治疗方法和 "一刀切 "的治疗开发方法也越来越多地被纳入考虑范围。此外,还在探索使用真实世界数据来提高临床试验的效率。这些方法有望进一步提高多发性骨髓瘤治疗的个体化和效率。
[Current status and future perspective of clinical trials for patients with multiple myeloma].
There are two main types of clinical trials: industry-sponsored trials and investigator-initiated trials. Both of these, like the two sets of wheels on a car, are essential to development of treatments. Numerous clinical trials have been conducted in multiple myeloma, contributing to the development of new drugs and the current treatment landscape. Highly effective novel immunotherapies, such as bispecific antibodies and chimeric antigen receptor T-cell therapy, have emerged, and could be incorporated into the treatment landscape in the near future. However, given the improved performance of current standard therapies, the drawbacks (e.g., toxicity) of immunotherapy can be expected to outweigh the benefits (efficacy) in some patients. Therefore, clinical trials are designed to evaluate treatments stratified based on factors such as post-treatment efficacy and disease risk, and stratified treatment approaches are increasingly being considered as well as one-size-fits-all approaches to treatment development. In addition, the use of real-world data is being explored to make clinical trials more efficient. These approaches are expected to further improve the individualization and efficiency of multiple myeloma treatment.