Abstract
BACKGROUND: This meta-analysis aimed to evaluate the efficacy of Daratumumab compared to control treatments in multiple myeloma across subgroups, including relapsed or refractory (RRMM), newly diagnosed transplant-eligible (ND/ESCT), and transplant-ineligible (ND/ISCT) patients. MATERIALS AND METHODS: A comprehensive literature search was conducted across PubMed, Scopus, and Web of Science. Randomized controlled trials and comparative studies evaluating Daratumumab versus control treatments in multiple myeloma patients were included. A random-effects model was employed to calculate pooled effect estimates of overall response rate (ORR), progression or death (PRD), minimum residual disease (MRD) negativity, and mortality. RESULTS: The analysis included data from 35 studies, 21 studies (n=7,604 patients) in the RRMM subgroup, 12 studies (n=10,216 patients) in the ND/ISCT subgroup, and 6 studies (n=4,619 patients) in the ND/ESCT subgroup, comprising 22,439 patients (including healthy controls). Daratumumab significantly improved ORR (OR: 2.58, 95% CI: 2.26-2.93, P0.01) and MRD negativity rates across all subgroups. PRD risk was lower in the Daratumumab group (RD: -0.14, 95% CI: -0.16 to -0.12), with consistent efficacy across RRMM, ND/ESCT, and ND/ISCT patients. CONCLUSION: This meta-analysis confirms Daratumumab's significant efficacy across multiple patient subgroups, providing broad clinical benefits in multiple myeloma treatment. While some heterogeneity and potential publication bias were observed, Daratumumab remains a robust therapeutic option for extending progression-free and overall survival.