Zhipan Zheng1, Kai Lin2. 1. Department of Trauma Surgery, Hubei Hanchuan People's Hospital Hanchuan, Hubei Province, China. 2. Department of Interventional Vascular Surgery, Hubei Hanchuan People's Hospital Hanchuan, Hubei Province, China.
Abstract
OBJECTIVE: To explore the efficacy and safety of ixazomib and lenalidomide combined with dexamethasone (DXMS) in the treatment of multiple myeloma (MM). METHODS: A total of 80 patients with newly diagnosed MM were randomly divided into the ID group (ixazomib + DXMS, n=40) and the RD group (lenalidomide + DXMS, n=40). All patients were given DXMS orally on the 1st, 8th, 15th, and 22nd day of the treatment cycle (20 mg each time). The patients in the ID group also received 4 mg of ixazomib citrate capsules orally on the 1st, 8th, and 15th day of the treatment cycle, whereas those in the RD group received 25 mg of lenalidomide capsules orally from the 1st to the 21st day of the treatment cycle continuously. The primary outcome measure was progression-free survival (PFS) within 5 years, and the secondary outcome measures were overall survival (OS), overall response rate (ORR), quality of life, and safety. RESULTS: The median PFS and median OS in the ID group were similar to those in the RD group (30.03 and 50.21 months vs. 25.04 and 46.33 months, both P>0.05). The ID group had higher complete remission rate (13 cases vs. 5 cases, P<0.05), but similar ORR compared with the RD group (90.00% vs. 82.50%, P>0.05). After treatment, the pain intensity assessed by Numeric Rating Scale and the functional impairment measured by Karnofsky Performance Status Scale of the two groups were both relieved (both P<0.001), and no intergroup differences in these two markers were observed (both P>0.05). The incidence of grade 1-2 peripheral neuropathy in the ID group was higher than that in the RD group (30.00% vs. 20.00%, P=0.032). There were no differences in other adverse reactions between the two groups (all P>0.05). CONCLUSION: Compared with the combination of lenalidomide and DXMS, ixazomib combined with DXMS can achieve higher complete remission rate and more improved PFS and OS in patients with newly diagnosed MM, which is a safe and effective method. AJTR
RCT Entities:
OBJECTIVE: To explore the efficacy and safety of ixazomib and lenalidomide combined with dexamethasone (DXMS) in the treatment of multiple myeloma (MM). METHODS: A total of 80 patients with newly diagnosed MM were randomly divided into the ID group (ixazomib + DXMS, n=40) and the RD group (lenalidomide + DXMS, n=40). All patients were given DXMS orally on the 1st, 8th, 15th, and 22nd day of the treatment cycle (20 mg each time). The patients in the ID group also received 4 mg of ixazomib citrate capsules orally on the 1st, 8th, and 15th day of the treatment cycle, whereas those in the RD group received 25 mg of lenalidomide capsules orally from the 1st to the 21st day of the treatment cycle continuously. The primary outcome measure was progression-free survival (PFS) within 5 years, and the secondary outcome measures were overall survival (OS), overall response rate (ORR), quality of life, and safety. RESULTS: The median PFS and median OS in the ID group were similar to those in the RD group (30.03 and 50.21 months vs. 25.04 and 46.33 months, both P>0.05). The ID group had higher complete remission rate (13 cases vs. 5 cases, P<0.05), but similar ORR compared with the RD group (90.00% vs. 82.50%, P>0.05). After treatment, the pain intensity assessed by Numeric Rating Scale and the functional impairment measured by Karnofsky Performance Status Scale of the two groups were both relieved (both P<0.001), and no intergroup differences in these two markers were observed (both P>0.05). The incidence of grade 1-2 peripheral neuropathy in the ID group was higher than that in the RD group (30.00% vs. 20.00%, P=0.032). There were no differences in other adverse reactions between the two groups (all P>0.05). CONCLUSION: Compared with the combination of lenalidomide and DXMS, ixazomib combined with DXMS can achieve higher complete remission rate and more improved PFS and OS in patients with newly diagnosed MM, which is a safe and effective method. AJTR
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