biostudies-literatureLandgren CONCI NIH HHSJanssen Research and Development1840-1852https://www.ebi.ac.uk/biostudies/studies/S-EPMC7326703biostudies-literatureUnknown34(7)Current guidelines for smoldering multiple myeloma (SMM) recommend active monitoring until the onset of multiple myeloma (MM) before initiating treatment or enrollment in a clinical trial. Earlier intervention may delay progression to MM. In CENTAURUS, 123 patients with intermediate-risk or high-risk SMM were randomly assigned to daratumumab 16 mg/kg intravenously on extended intense (intense), extended intermediate (intermediate), or short dosing schedules. At the prespecified primary analysis (15.8-month median follow-up), the complete response (CR) rates (co-primary endpoint) were 2.4%, 4.9%, and 0% for intense, intermediate, and short dosing, respectively; the co-primary endpoint of CR rate >15% was not met. Progressive disease (PD)/death rates (number of patients who progressed or dieLeukemiaDaratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).PMC7326703P30 CA008748P30 CA138292Voorhees PBeksac MKuppens SHofmeister CCQi MJenner MWCavo MBandekar RMoreau PSpencer AWilliams CLandgren COEstell JAChari AClemens PLNeff Tvan de Donk NWCJGoldschmidt HCohen YCHeuck CSandhu IfalseDaratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).Current guidelines for smoldering multiple myeloma (SMM) recommend active monitoring until the onset of multiple myeloma (MM) before initiating treatment or enrollment in a clinical trial. Earlier intervention may delay progression to MM. In CENTAURUS, 123 patients with intermediate-risk or high-risk SMM were randomly assigned to daratumumab 16 mg/kg intravenously on extended intense (intense), extended intermediate (intermediate), or short dosing schedules. At the prespecified primary analysis (15.8-month median follow-up), the complete response (CR) rates (co-primary endpoint) were 2.4%, 4.9%, and 0% for intense, intermediate, and short dosing, respectively; the co-primary endpoint of CR rate >15% was not met. Progressive disease (PD)/death rates (number of patients who progressed or die2020-01-01T00:00:00Z2020 Jul2026-05-09T00:32:12.443Z2020-07-11T07:04:10ZS-EPMC73267033202495010.1038/s41375-020-0718-z