CARTITUDE-4 研究中 cilta-cel 自体细胞疗法治疗复发或难治性多发性骨髓瘤的通俗语言摘要。
Plain language summary of the CARTITUDE-4 study of ciltacabtagene autoleucel for the treatment of people with relapsed or refractory multiple myeloma.
机构信息
Cancer Center Clínica Universidad de Navarra, CCUN, CIMA; IDISNA, CIBERONC, Pamplona, Spain.
Medical College of Wisconsin, Milwaukee, WI, USA.
出版信息
Future Oncol. 2024;20(33):2509-2520. doi: 10.1080/14796694.2024.2376973. Epub 2024 Aug 7.
WHAT IS THIS SUMMARY ABOUT?: This is a summary of a called CARTITUDE-4. This trial compared the anti-cancer therapy ciltacabtagene autoleucel (or cilta-cel) with standard therapies in people who have multiple myeloma, a cancer that affects specific kinds of blood cells called plasma cells. The people in the study had been treated with 1 to 3 previous treatments for multiple myeloma, including a common anti-myeloma treatment called lenalidomide, but their multiple myeloma did not get better.
HOW WAS THE STUDY IN THIS SUMMARY CONDUCTED?: About half of the 419 participants in this study received cilta-cel, while the other half received standard therapies, or therapies that are commonly used to treat multiple myeloma. Participants who received cilta-cel had a type of immune cell called T cells collected from their blood and genetically modified to recognize a specific protein found on myeloma cells. These modified T cells, which comprise cilta-cel, were then infused back into the bloodstream.
WHAT WERE THE RESULTS OF THE STUDY?: After approximately 1 year in the study, more participants were alive without their cancer getting worse in the cilta-cel group (76%) than in the standard therapies group (49%). The most common in both groups were infections and low blood cell counts. Cytokine release syndrome (a potentially serious side effect caused by overactivation of the immune system) was common but mostly mild. (including immune effector cell-associated neurotoxicity syndrome, which can cause symptoms such as headaches, changes in consciousness, and difficulty with memory, attention, speaking, or understanding others) were less common and were reported in 20.5% of participants treated with cilta-cel.
WHAT WERE THE MAIN CONCLUSIONS REPORTED BY THE RESEARCHERS?: In CARTITUDE-4, more participants treated with cilta-cel showed improvements and were alive with control of their disease 12 months after receiving cilta-cel compared with participants who received standard therapies. NCT04181827 (CARTITUDE-4) (ClinicalTrials.gov).
这是一项名为 CARTITUDE-4 的研究的摘要。该试验比较了抗癌疗法 cilta-cel（或 cilta-cel）与多发性骨髓瘤患者标准疗法的疗效，多发性骨髓瘤是一种影响称为浆细胞的特定类型血细胞的癌症。该研究中的患者接受了 1 至 3 种先前的多发性骨髓瘤治疗，包括一种常用的骨髓瘤治疗药物来那度胺，但他们的多发性骨髓瘤没有好转。
在这项摘要中研究是如何进行的？研究中的 419 名参与者约有一半接受了 cilta-cel，而另一半接受了标准疗法，即常用于治疗多发性骨髓瘤的疗法。接受 cilta-cel 的患者从血液中收集一种称为 T 细胞的免疫细胞，并对其进行基因修饰以识别骨髓瘤细胞上发现的特定蛋白。这些经过修饰的 T 细胞，即 cilta-cel，然后被回输到血液中。
研究的结果是什么？在研究中大约 1 年后，在 cilta-cel 组中，更多的患者在没有癌症恶化的情况下存活（76%），而在标准治疗组中为 49%。两组中最常见的不良反应是感染和血细胞计数低。细胞因子释放综合征（一种由免疫系统过度激活引起的潜在严重副作用）很常见，但大多为轻度。神经毒性综合征（一种可能导致头痛、意识改变以及记忆、注意力、说话或理解他人能力受损等症状的免疫效应细胞相关神经毒性综合征）较少见，在接受 cilta-cel 治疗的 20.5%的患者中报告了该综合征。
研究人员报告的主要结论是什么？在 CARTITUDE-4 中，与接受标准治疗的患者相比，接受 cilta-cel 治疗的患者在接受 cilta-cel 治疗 12 个月后，更多患者显示出改善，并且疾病得到控制，存活下来。NCT04181827（CARTITUDE-4）（ClinicalTrials.gov）。
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