Surya Prakash Vadlamani, Nair Rajesh R, Soneji Dharmesh, Thareja Sandeep, Rao Pankaj P, Debnath Jyotindu, Chowdhary Gurjeet Singh, Guleria Bhupesh, Kushwaha Neerja, Biswas Amit, H Rama, Bohra Vijay, Khurana Harshit, Sharma Sanjeevan, Mishra Kundan
Department of Medical Oncology, Command Hospital, Lucknow, IND.
Department of Medicine, Command Hospital, Lucknow, IND.
Cureus. 2024 Dec 21;16(12):e76164. doi: 10.7759/cureus.76164. eCollection 2024 Dec.
There is no standard treatment to accelerate recovery from melphalan-induced thrombocytopenia in multiple myeloma (MM) patients undergoing autologous stem cell transplantation (ASCT). Romiplostim, a thrombopoietin receptor agonist, has been developed to upregulate platelet production.
This study aimed to assess the efficacy and safety of romiplostim in reducing platelet transfusions post-ASCT in MM patients.
This was an investigator-initiated, single-center, open-label, comparative pilot study conducted from January to December 2022. We evaluated 18 melphalan-conditioned MM patients treated with pegylated granulocyte colony-stimulating growth factor (GCSF) (6 mg subcutaneously, SC, on day 2) and romiplostim (250 mcg SC on day 3) post-ASCT (romiplostim cohort). We compared them with 56 MM patients who had undergone ASCT and received GCSF alone (conventional or retrospective cohort, enrolled from 2015 to 2021). Efficacy endpoints included the number of mean single donor platelet (SDP) and packed red blood cell (PRBC) transfusions, time to platelet and neutrophil engraftment, and safety and tolerability assessments.
In the romiplostim cohort, the average number of SDP transfusions required was significantly lower than that in the conventional cohort (1.39 vs. 3.40, p = 0.0001). Platelet engraftment occurred significantly faster in the romiplostim cohort versus the conventional cohort (9.72 vs. 12.57 days, p = 0.0018). Neutrophil engraftment days and PRBC transfusion requirements were comparable between the two groups. No deaths or major safety concerns were reported.
Romiplostim demonstrated an improved efficacy and a favorable safety profile compared to the conventional approach in patients undergoing ASCT.
对于接受自体干细胞移植(ASCT)的多发性骨髓瘤(MM)患者,目前尚无标准治疗方法可加速美法仑诱导的血小板减少症的恢复。罗米司亭是一种血小板生成素受体激动剂,已被开发用于上调血小板生成。
本研究旨在评估罗米司亭在减少MM患者ASCT后血小板输注方面的疗效和安全性。
这是一项由研究者发起的、单中心、开放标签的比较性试点研究,于2022年1月至12月进行。我们评估了18例接受美法仑预处理的MM患者,这些患者在ASCT后接受了聚乙二醇化粒细胞集落刺激生长因子(GCSF)(第2天皮下注射6mg)和罗米司亭(第3天皮下注射250mcg)治疗(罗米司亭队列)。我们将他们与56例接受ASCT且仅接受GCSF治疗的MM患者进行比较(传统或回顾性队列,于2015年至2021年入组)。疗效终点包括平均单次供体血小板(SDP)和红细胞悬液(PRBC)输注次数、血小板和中性粒细胞植入时间,以及安全性和耐受性评估。
在罗米司亭队列中,所需的SDP输注平均次数显著低于传统队列(1.39比3.40,p = 0.0001)。与传统队列相比,罗米司亭队列中血小板植入明显更快(9.72天比12.57天,p = 0.0018)。两组之间中性粒细胞植入天数和PRBC输注需求相当。未报告死亡或重大安全问题。
与传统方法相比,罗米司亭在接受ASCT的患者中显示出更好的疗效和良好的安全性。