The efficacy and safety profile of ixazomib/lenalidomide/dexamethasone in relapsed/refractory multiple myeloma: a multicenter real-world study in China
10.3760/cma.j.issn.0253-2727.2021.08.003
- VernacularTitle: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
- Author:
Yang YANG
1
;
Zhongjun XIA
;
Wenhao ZHANG
;
Chengcheng FU
;
Li BAO
;
Bing CHEN
;
Kaiyang DING
;
Sili WANG
;
Jun LUO
;
Bingzong LI
;
Luoming HUA
;
Wei YANG
;
Xin ZHOU
;
Liang WANG
;
Tianhong XU
;
Weida WANG
;
Guolin WU
;
Yun HUANG
;
Jing LI
;
Peng LIU
Author Information
1. 复旦大学附属中山医院血液科，上海 200032
- Keywords:
Multiple myeloma;
Ixazomib;
Lenalidomide;
Treatment outcome;
Safety
- From:
Chinese Journal of Hematology
2021;42(8):628-634
- CountryChina
- Language:Chinese
-
Abstract:
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.
