biostudies-literatureUnknown57(1)Quan L<h4>Objective</h4>Smoldering multiple myeloma (SMM) is a slowly progressive, asymptomatic plasma cell disorder. This meta-analysis evaluated the efficacy and safety of novel agent-based therapies for SMM, particularly high-risk patients.<h4>Methods</h4>PubMed, Embase, Web of Science, Ovid MEDLINE, Scopus and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) and non-randomized studies from 2003 to 2024.<h4>Results</h4>Nineteen studies were included, comprising 5 RCTs and 14 non-randomized, single-arm trials. These studies involved a total of 1217 patients. Pooled analysis of intervention groups showed progression-free survival (PFS) and overall survival (OS) rate at 12 months of 94% (95% CI, 89%-98%) and 99% (95% CI, 97%-100%), respectively. The overall response rate Annals of medicine2560679https://www.ebi.ac.uk/biostudies/studies/S-EPMC12466189biostudies-literatureEfficacy and toxicity of treatment of smoldering multiple myeloma: a systematic review and meta-analysis.PMC12466189Ma CCao XSun CQuan LLi QfalseEfficacy and toxicity of treatment of smoldering multiple myeloma: a systematic review and meta-analysis.<h4>Objective</h4>Smoldering multiple myeloma (SMM) is a slowly progressive, asymptomatic plasma cell disorder. This meta-analysis evaluated the efficacy and safety of novel agent-based therapies for SMM, particularly high-risk patients.<h4>Methods</h4>PubMed, Embase, Web of Science, Ovid MEDLINE, Scopus and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) and non-randomized studies from 2003 to 2024.<h4>Results</h4>Nineteen studies were included, comprising 5 RCTs and 14 non-randomized, single-arm trials. These studies involved a total of 1217 patients. Pooled analysis of intervention groups showed progression-free survival (PFS) and overall survival (OS) rate at 12 months of 94% (95% CI, 89%-98%) and 99% (95% CI, 97%-100%), respectively. The overall response rate 2025-01-01T00:00:00Z2025 Dec2026-05-01T03:16:04.37Z2026-05-01T03:10:16.666ZS-EPMC124661894099410010.1080/07853890.2025.2560679