摘要
Abstract
Objective:To evaluate the efficacy of different doses of daratumumab in relapsed/refractory multiple myeloma(RRMM).Methods:From January 2020 to December 2021,120 RRMM patients were randomly assigned to low-dose(8 mg/kg)or high-dose(16 mg/kg)daratumumab groups(n=60 each).Serum β2-microglobulin,M protein,T lymphocyte subsets,clinical efficacy,and adverse reactions were compared.Results:After treatment,serum IgG,IgA,IgM,C3,and C4 decreased in both groups,with more pronounced reductions in the high-dose group(P＜0.05).Regulatory T cells(Treg)decreased significantly more in the high-dose group(P＜0.05),while CD3+,CD4+,and CD4+/CD8+ratios increased more(P＜0.05).No difference in overall response rate(ORR)or stringent complete response(sCR)plus complete response(CR)was found(P＞0.05),but the high-dose group had a higher rate of sCR+CR+very good partial response(VGPR)(P＜0.05).Adverse reaction incidences were similar(P＞0.05).Conclusion:Compared with 8 mg/kg,16 mg/kg daratumumab improves immune function,enhances deep response rate(sCR+CR+VGPR),and maintains safety.关键词
达雷妥尤单抗/复发难治性多发性骨髓瘤/剂量依赖性/免疫功能/安全性Key words
daratumumab/relapsed/refractory multiple myeloma/dose dependence/immune function/safety分类
医药卫生
