Chapters Transcript Video Omar Nadeem, MD discusses results of the Phase II d-PRISM study Daratumumab in high-rish MGUS and low-risk smoldering myeloma So as we know, daratumumab was recently approved for patients with high-risk smoldering myeloma based on the results from the Aquila trial, and what we also know about high-risk smoldering myeloma is that the genomic features within that disease state are very similar to what we see in multiple myeloma. So as a result, we aim to study datumumab one step before high-risk smoldering myeloma in patients that have low-risk smoldering myeloma or high-risk MGUS. So the eligibility of this study was defined for high-risk MGUS as having two out of the three known high-risk features, such as an abnormal light chain ratio, an M protein more than 1.5 g, or a non-IgG M protein. And for low-risk smoldering myeloma, they had to have one of the original Mayo 2008 criteria, so an M spike more than 3 g, uh, more than 10% bone marrow plasma cells, or a light chain ratio that was abnormal, uh, of more than 8. we gave datumumab, uh, for 20 cycles, and the primary endpoint of this study was VGPR rate or greater after those 20 cycles. Uh, so we enrolled 41 patients, the median age was 59. A majority of these patients were low-risk smoldering myeloma at 88%, and 12% of patients that were enrolled met the high risk MGUS criteria. Majority of patients had, uh, standard risk, uh, cytogenetics and were low or intermediate risk when it came to the newer 20 to 20 criteria. Uh, the, the treatment was overall pretty well tolerated. There were very few grade 3 or greater toxicities. Uh, respiratory infections occurred in only 22% of patients, and there were no incidents of febrile neutropenia or any grade 3 infections. Uh, on this study, neutropenia, uh, as a whole was seen in about 29% of patients. So in terms of efficacy, the overall response rate was 54% and 17% of patients, uh, met, uh, VGPR or better. Uh, this is in line with what we know about single agent activity of dairy. tumumab based on the Aquila trial and some of the other previous studies in this, uh, in this space. Uh, the median follow-up of all patients is about 63 months, and the median overall survival has not been reached. Uh, Two patients progressed to multiple myeloma, and progression was diagnosed based on the slim criteria. And then 21% of uh 21 patients, which is 51%, uh, developed biochemical progression, and the median time to biochemical progression was 59.5 months, and this was significantly longer in patients that achieved a deeper response with VGPR or better. Published December 18, 2025 Created by Related Presenters Omar Nadeem, MD Medical Oncology View Full profile
