伊沙佐米、来那度胺、地塞米松治疗复发/难治多发性骨髓瘤的疗效与安全性分析：一项国内多中心真实世界研究

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.