Meta-analysis Of The Efficacy And Safety Of CD38 Monoclonal Antibody In The Treatment Of Multiple Myeloma

Objective: Based on the existing meta-analysis,this paper conducted a meta-analysis of a randomized controlled trial(RCT)for the treatment of patients with relapsed and refractory multiple myeloma(RRMM),in order to evaluate the efficacy and safety of CD38 monoclonal antibody in this population and provide more theoretical basis for clinical treatment.Methods: The major databases(including web of science,Pub Med,EMBASE,the Cochrane Library,etc.)were searched by computer to screen the randomized controlled trials of CD38 monoclonal antibody in the treatment of recurrent /refractory multiple myeloma published from the establishment of the database to December 2021.The overall response rate,progression free survival,incidence of adverse events in the blood system(such as anemia,thrombocytopenia,neutropenia,etc.)were The incidence of non hematological adverse events(such as diseases of respiratory system,digestive system,cardiovascular system,etc.)was used as the outcome index of the study,and the above indexes were entered into Review Manager5.3 and stata15.0 analysis system for systematic evaluation.Results: After screening,a total of 7 RCT studies were included,with a total of2657 patients[1474 patients were treated with drugs containing CD38 monoclonal antibody;another 1183 patients were treated with traditional proteasome inhibitors(PI)or immunomodulators(IMi DS)].The results of meta-analysis showed that in terms of curative effect,compared with the control group,the total response rate(ORR),≥very good partial remission rate(≥ VGPR),≥ complete remission rate(≥ CR)and minimal residual negative rate(MRD)of RRMM in CD38 monoclonal antibody group were significantly improved[RR=1.26,95%CI(1.14,1.40),P<0.05;RR=1.43,95%CI(1.07,1.91),P<0.05;RR=2.57,95%CI(1.89,3.50),P<0.05;RR=5.28,95%CI(2.80,9.96),P<0.05],and the progression free survival(PFS)of patients in CD38 monoclonal antibody group was prolonged[HR=0.47,95%CI(0.37,0.60),P<0.05].In terms of safety,the inter group comparison of the incidence of non hematological adverse events showed that the incidence of upper respiratory tract infection,pneumonia,emergency adverse reactions,diarrhea and back pain in the CD38 monoclonal antibody group was high and statistically different[RR=1.57,95%CI(1.37,1.78),P<0.05;RR=1.35,95%CI(1.13,1.61),P<0.05;RR=1.17,95%CI(1.06,1.30),P<0.05;RR=1.51,95%CI(1.34,1.71),P<0.05;RR=1.35,95%CI(1.10,1.65),P<0.05].There was no significant difference in the incidence of other non hematological adverse events such as constipation,fatigue and hypertension between the two groups.The adverse events with statistical differences were graded,the comparison between groups showed that there were statistical differences in ≥ grade 3 upper respiratory tract infection,≥ grade 3 pneumonia and ≥grade 3 diarrhea[RR=1.99,95%CI(1.14,3.46),P<0.05;RR=1.33,95%CI(1.10,1.59),P<0.05;RR=2.35,95%CI(1.51,3.65),P<0.05].The incidence of thrombocytopenia and neutropenia in hematological adverse events was high in CD38 monoclonal antibody group with statistical difference[RR=1.12,95%CI(1.03,1.22),P<0.05;RR=1.39,95%CI(1.07,1.81),P<0.05],there was no statistical difference in the incidence of lymphocytopenia and anemia between the two groups,while there were statistical differences in the incidence of thrombocytopenia,neutropenia and lymphocytopenia in the ≥3 grade adverse reactions of the blood system[RR=1.27,95%CI(1.11,1.45),P<0.05;RR=1.47,95%CI(1.21,1.78),P<0.05;RR=1.77,95%CI(1.09,2.87),P<0.05]。Conclusion:1.CD38 monoclonal antibody has good curative effect in the treatment of RRMM,and significantly improves the total response rate(ORR),≥ very good partial remission rate(≥ VGPR),≥ complete remission rate(≥ CR)and the negative rate of minimal residual(MRD);2.According to the results of subgroup analysis,patients’ previous treatment times and ISS stage are important factors affecting progression free survival(PFS).Patients with smaller ISS stage and less previous treatment times can obtain longer progression free survival(PFS)with CD38 monoclonal antibody treatment;3.In non hematological adverse events,compared with the control group,the CD38 monoclonal antibody group had a higher incidence of five adverse reactions:upper respiratory tract infection,pneumonia,emergency adverse events,diarrhea and back pain.In grade 3 and above non hematological adverse events,the incidence of upper respiratory tract infection,pneumonia and diarrhea in the CD38 monoclonal antibody group was higher than that in the control group.In hematological adverse events,the CD38 monoclonal antibody group was more prone to thrombocytopenia and neutropenia than the control group.