Scarce data exist on double maintenance in transplant-eligible high-risk (HR) newly diagnosed multiple myeloma (NDMM) patients. This prospective phase 2 study enrolled 120 transplant-eligible NDMM patients. The treatment consisted of four cycles of ixazomib–lenalidomide–dexamethasone (IRD) induction plus autologous stem cell transplantation followed by IRD consolidation and cytogenetic risk-based maintenance therapy with lenalidomide + ixazomib (IR) for HR patients and lenalidomide (R) alone for NHR patients. The main endpoint of the study was undetectable minimal residual disease (MRD) with sensitivity of <10−5by flow cytometry at any time, and other endpoints were progression-free survival (PFS) and overall survival (OS). We present the preplanned analysis after the last patient has been two years on maintenance. At any time during protocol treatment, 28% (34/120) had MRD < 10−5at least once. At two years on maintenance, 66% of the patients in the HR group and 76% in the NHR group were progression-free (p= 0.395) and 36% (43/120) were CR or better, of which 42% (18/43) had undetectable flow MRD <10−5. Altogether 95% of the patients with sustained MRD <10−5, 82% of the patients who turned MRD-positive, and 61% of those with positive MRD had no disease progression at two years on maintenance (p< 0.001). To conclude, prolonged maintenance with all-oral ixazomib plus lenalidomide might improve PFS in HR patients.
关于移植适宜的高危新诊断多发性骨髓瘤患者采用双重维持治疗的数据较为有限。这项前瞻性II期研究纳入了120例移植适宜的新诊断多发性骨髓瘤患者。治疗方案包括四个周期的伊沙佐米-来那度胺-地塞米松诱导治疗联合自体干细胞移植，随后进行伊沙佐米-来那度胺-地塞米松巩固治疗，并根据细胞遗传学风险进行维持治疗：高危患者采用来那度胺联合伊沙佐米，非高危患者单用来那度胺。研究主要终点为治疗期间任意时间点流式细胞术检测灵敏度达10⁻⁵的不可测微小残留病，次要终点包括无进展生存期和总生存期。本文报告末例患者进入维持治疗两年后的预设分析结果。在方案治疗期间的任意时间点，28%（34/120）的患者至少一次达到微小残留病<10⁻⁵水平。维持治疗两年时，高危组66%和非高危组76%的患者保持无进展生存（p=0.395），36%（43/120）的患者达到完全缓解或更好疗效，其中42%（18/43）的患者流式检测微小残留病<10⁻⁵。总体而言，维持治疗两年时，持续微小残留病<10⁻⁵的患者中95%、微小残留病转阳患者中82%、以及微小残留病持续阳性患者中61%未出现疾病进展（p<0.001）。结论表明，采用全口服伊沙佐米联合来那度胺的延长维持治疗可能改善高危患者的无进展生存期。
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