Real-world study of daratumumab-based triplet regimens in the treatment of multiple myeloma patients

LV Shuxin; FANG Baijun; ZANG Yuzhu; WANG Shijie; QIN Ling

doi:10.3969/j.issn.1009-0460.2025.07.015

Abstract：Objective To explore the efficacy and safety of daratumumab(Dara)-based triplet regimens in the treatment of multiple myeloma(MM)in the real-world setting.Methods A retrospective analysis was conducted on the clinical data of 61 MM patients treated with Dara-based triplet regimens at the First Affiliated Hospital of Henan University of Science and Technology,Henan Cancer Hospital,and Henan Provincial People's Hospital from November 2020 to June 2024.Based on cytogenetic risk and treatment history,Dara-based regimens included DVd,DRd,DPd,DKd,and DId,combining it with bortezomib,lenalidomide,pomalidomide,carfilzomib,or ixazomib,all with dexamethasone.The administration regimen for Dara was 16 mg/kg via intravenous infusion,with an initial phase(weeks 1-8)of weekly dosing,followed by biweekly dosing in weeks 9-24,and a maintenance phase(after week 24)of dosing every 4 weeks.Each cycle consisted of 4 doses.Treatment efficacy was evaluated according to the response criteria outlined in the Chinese Guidelines for the Diagnosis and Management of Multiple Myeloma(2022 Revision),while adverse reactions were assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events,version 5.0.Follow-up data were analyzed to determine the overall survival(OS)and progression-free survival(PFS)of patients receiving Dara-based therapy.Results Among the 61 MM patients,the distribution across treatment groups was as follows:DVd group(19 cases,31.1%),DRd group(18 cases,29.5%),DPd group(18 cases,29.5%),DKd group(3 cases,4.9%),and DId group(3 cases,4.9%).The overall response rate reached 81.9%(50/61).The best achieved disease responses were stringent complete response in 4.9%(3 cases),complete response in 37.7%(23 cases),very good partial response in 21.3%(13 cases),partial response in 18.0%(11 cases),minimal response in 6.6%(4 cases),stable disease in 8.2%(5 cases),and disease progression in 3.3%(2 cases).After a median follow-up of 15.1 months(range:1.4-32.5 months),the 30-month OS rate was 81.4%,and the 30-month PFS rate was 58.6%.The median OS and PFS were not yet reached.The PFS curves showed no significant difference between MM patients aged<65 years and those≥65 years(P=0.398).However,a statistically significant disparity was observed among patients receiving first-line,second-line,and third-line or higher treatments(P<0.001).In contrast,no significant variation in PFS was found across the DVd,DPd,and DRd treatment regimens(P=0.487).The Dara-based triple-drug regimen shows no significant impact on stem cell collection or hematopoietic reconstitution,while demonstrating favorable efficacy in MM patients with concomitant amyloidosis.Conclusion Dara demonstrates favorable efficacy and manageable safety in MM patients,improving clinical outcomes and prolonging survival.