The all-oral combination of ixazomib, cyclophosphamide, and dexamethasone (ICD) is well tolerated and effective in newly diagnosed and relapsed multiple myeloma (MM). We carried out MUKeight, a randomised, controlled, open, parallel group, multi-centre phase II trial in patients with relapsed MM after prior treatment with thalidomide, lenalidomide, and a proteasome inhibitor (ISRCTN58227268), with the primary objective to test whether ICD has improved clinical activity compared to cyclophosphamide and dexamethasone (CD) in terms of progression-free survival (PFS). Between January 2016 and December 2018, 112 participants were randomised between ICD (n = 58) and CD (n = 54) in 33 UK centres. Patients had a median age of 70 years and had received a median of four prior lines of therapy. 74% were classed as frail. Median PFS in the ICD arm was 5.6 months, compared to 6.7 months with CD (hazard ratio (HR) = 1.21, 80% CI 0.9–1.6, p = 0.3634). Response rates and overall survival were not significantly different between ICD and CD. Dose modifications or omissions, and serious adverse events (SAEs), occurred more often in the ICD arm. In summary, the addition of ixazomib to cyclophosphamide and dexamethasone did not improve outcomes in the comparatively frail patients enroled in the MUKeight trial.
伊沙佐米、环磷酰胺和地塞米松（ICD）的全口服联合方案在新诊断及复发多发性骨髓瘤（MM）患者中具有良好的耐受性和疗效。我们开展了MUKeight试验（ISRCTN58227268）——一项针对既往接受过沙利度胺、来那度胺及蛋白酶体抑制剂治疗的复发MM患者的随机、对照、开放、平行组、多中心II期临床试验，其主要目的是比较ICD方案与环磷酰胺联合地塞米松（CD）方案在无进展生存期（PFS）方面是否具有更优的临床活性。2016年1月至2018年12月期间，英国33个中心共112名参与者被随机分配至ICD组（n=58）和CD组（n=54）。患者中位年龄70岁，既往接受过中位四线治疗，其中74%被评估为虚弱状态。ICD组中位PFS为5.6个月，而CD组为6.7个月（风险比[HR]=1.21，80%置信区间0.9-1.6，p=0.3634）。两组的缓解率和总生存期无显著差异。ICD组剂量调整或遗漏情况以及严重不良事件的发生率更高。总之，在MUKeight试验纳入的相对虚弱的患者中，在环磷酰胺和地塞米松基础上加用伊沙佐米并未改善临床结局。
肿瘤(癌症)患者之家