Objective: To evaluate the efficacy and safety profile of ixazomib/lenalidomide/dexamethasone (IRd) in Chinese patients with relapsed/refractory multiple myeloma (MM) . Methods: This study comprising 14 medical centers in China included patients with relapsed/refractory MM who received at least. Ixazomib at an initial oral dose of 4 mg was administered. Seven patients had dose adjustment to 3 mg at the time of first dose. The lenalidomide doses were adjusted according to creatinine clearance rate. The efficacy and safety were evaluated every cycle. Results: In the study cohort of 74 patients, the median age was 65 years and 11 (14.9% ) patients received over three lines of therapy. Overall response rate (ORR) was 54.1% (40/74) , and 7 (9.5% ) , 14 (18.9% ) , and 19 (25.7% ) patients achieved stringent complete response or complete response, very good partial response, and partial response, respectively. The median progression-free survival and overall survival were 9.9 and 20 months, respectively. The median time to response was 1 month. The efficacy and survival outcome were similar to those reported in the Tourmaline-MM1 China Continuous Study. The ORR of patients refractory to bortezomib, lenalidomide, and bortezomib plus lenalidomide were 52.0% (13/25) , 57.1% (4/7) , and 33.3% (6/18) , respectively. The rate of grade 3-4 adverse events was 36.5% (27/74) . Common hematological toxicities were anemia, thrombocytopenia, lymphopenia, and neutropenia. Common non-hematological toxicities were fatigue, gastrointestinal symptoms, and infections. Two cases of grade 3 peripheral neuropathy were reported. The patients eligible for the Tourmaline-MM1 China Continuous Study had a higher ORR than the ineligible patients [77.8% (14/18) vs 46.4% (26/56) , P=0.020]. There was no difference in the rate of grade 3-4 adverse events [33.3% (6/18) vs 37.5% (21/56) , P=0.749]. Conclusion: The IRd regimen had good efficacy and acceptable toxicity in Chinese patients with relapsed/refractory MM.
目的： 评估伊沙佐米、来那度胺、地塞米松（IRd）方案治疗复发/难治多发性骨髓瘤（MM）的疗效及安全性。 方法： 纳入2018年7月至2020年5月于国内14个中心接受至少1个周期IRd方案治疗的复发/难治MM患者。除7例起始剂量作调整的患者以外，其余患者伊沙佐米起始剂量为4 mg。来那度胺剂量根据患者肌酐清除率进行调整。每周期进行疗效及安全性评估。 结果： 共纳入74例患者，中位年龄65岁，11例（14.9%）患者曾接受>三线治疗。总体反应率（ORR）为54.1%（40/74），其中7例（9.5%）达严格意义的完全缓解或完全缓解，14例（18.9%）达非常好的部分缓解，19例（25.7%）达部分缓解，中位无进展生存时间为9.9月，中位总生存时间为20个月，中位获得反应时间为1个月。总体疗效与生存结果与TOURMALINE-MM1中国延展性研究（TOURMALINE-MM1 CCS）相近。硼替佐米难治、来那度胺难治、两药均难治患者的ORR分别为52.0%（13/25）、57.1%（4/7）和33.3%（6/18）。3~4级不良事件（AE）发生率为36.5%（27/74）。主要血液学不良反应为贫血、血小板减少、淋巴细胞减少及中性粒细胞减少。主要非血液学不良反应为乏力、消化道症状及感染。2例患者出现3级周围神经病变。与不符合TOURMALINE-MM1 CCS试验入组标准的患者相比，符合入组标准的患者ORR更高[77.8%（14/18）对46.4%（26/56），P＝0.020]，两组3~4级AE发生率的差异无统计学意义[33.3%（6/18）对37.5%（21/56），P＝0.749]。 结论： IRd方案治疗复发/难治MM具有较好的疗效及安全性。.
Keywords: Ixazomib; Lenalidomide; Multiple myeloma; Safety; Treatment outcome.