The phase 3, double-blind, placebo-controlled TOURMALINE-MM3 study (NCT02181413) demonstrated improved progression-free survival with ixazomib maintenance versus placebo post autologous stem cell transplant (ASCT) in multiple myeloma patients. We report additional safety data from TOURMALINE-MM3 to inform adverse event (AE) management recommendations. Patients were randomized 3:2 to receive ixazomib (n = 395) or placebo (n = 261) on days 1, 8, and 15 of 28-day cycles for ~ 2 years or until progressive disease/toxicity. The initial 3-mg ixazomib dose was escalated to 4 mg in cycle 5, if tolerated in cycles 1–4. Safety was a secondary endpoint assessed in all treated patients; AEs were graded using Common Terminology Criteria for AEs v4.03. The rate of grade ≥ 3 AEs was higher in the ixazomib arm (19%) than in the placebo arm (5%), but the rate of discontinuation due to AEs was similar (7% vs. 5%). For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%. However, the majority of events were low-grade, manageable with supportive therapy or dose reduction, and reversible, and did not result in discontinuation. There was no evidence of cumulative, long-term, or late-onset toxicity with ixazomib maintenance. Ixazomib is an efficacious and tolerable option for post-ASCT maintenance. AEs associated with ixazomib maintenance can be managed in the context of routine post-ASCT supportive care due to the limited additional toxicity. ClinicalTrials.gov NCT02181413

三期，双盲，安慰剂对照的TOURMALINE-MM3研究（NCT02181413）证明，与多药骨髓瘤患者的自体干细胞移植（ASCT）后相比，依沙酮单抗维持治疗可改善无进展生存率。我们从TOURMALINE-MM3报告其他安全数据，以告知不良事件（AE）管理建议。患者按3：2的比例随机接受ixazomib（n =  395）或安慰剂（n = 261）在28天周期的第1、8和15天中，持续约2年或直到疾病/毒性逐渐恶化。如果第1-4周期可以耐受，那么第3周期ixaxomib的初始剂量会增加到第5周期的4 mg。安全性是所有治疗患者的次要终点。使用AE的通用术语标准v4.03对AE进行分级。依阿佐米布组的≥3级不良事件发生率（19％）高于安慰剂组（5％），但因不良事件引起的停药发生率相似（7％vs. 5％）。对于具有临床意义的AE，使用ixazomib较使用安慰剂的比率更高：恶心39％比15％，呕吐27％比11％，腹泻35％比24％，血小板减少症13％比3％，周围神经病变19％比15％ 。但是，大多数事件均为低度事件，可通过支持疗法或降低剂量进行治疗，并且可逆，并没有导致停产。没有证据表明依沙米布维持会产生累积，长期或晚期发作毒性。Ixazomib是ASCT后维护的有效且可耐受的选择。由于有限的额外毒性，可以在常规ASCT后支持治疗的情况下管理与ixazomib维持治疗相关的不良事件。ClinicalTrials.gov NCT02181413