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ASH 2024 | Phase II trial of daratumumab, bortezomib, lenalidomide and dexamethasone in HR-SMM
Omar Nadeem, MD, Dana-Farber Cancer Institute, Boston, MA, provides insight into a Phase II trial (B-PRISM; NCT04775550) of daratumumab, bortezomib, lenalidomide, and dexamethasone for the treatment of high-risk smoldering multiple myeloma (HR-SMM), highlighting the encouraging response rates and measurable residual disease (MRD) negativity rates observed to date. The second part of the trial is now enrolling. Patients who have achieved MRD negativity will go on observation, and those who are MRD positive will be randomized to receive further treatment or observation. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
Daratumumab as a single agent is showing benefit in this high-risk smoldering myeloma population based on the AQUILA trial. And now, you know, in newly diagnosed myeloma, we use the regimen of daratumumab with bortezomib, lenalidomide, and dexamethasone as one of the most commonly used frontline regimens. So can we improve depth of response in these high-risk smoldering myeloma patients and perhaps delay progression or prevent progression in these patients? So that was the intent of this study...
Daratumumab as a single agent is showing benefit in this high-risk smoldering myeloma population based on the AQUILA trial. And now, you know, in newly diagnosed myeloma, we use the regimen of daratumumab with bortezomib, lenalidomide, and dexamethasone as one of the most commonly used frontline regimens. So can we improve depth of response in these high-risk smoldering myeloma patients and perhaps delay progression or prevent progression in these patients? So that was the intent of this study.
It was a two-year treatment program with a modified schedule of daratumumab, RVd, to try to limit toxicity. And then this was driven by MRD. So patients that were MRD negative at those two years will come off trial and go on observation. And those that are positive will be randomized to two more years of daratumumab and lenalidomide or to observation. So it has a two-part component.
So we’ve presented this updated data at several of the meetings, but at this data cutoff, we’ve enrolled 45 patients. And this is a typical high-risk smoldering myeloma population. The majority of patients met high-risk criteria either by the 20/2/20 model or some of the other validated criteria. And so far, the response rates also look very good in this trial. We have an overall response rate of 98% and a complete response rate of over 60% in these patients. Some patients are now at that two-year mark for their MRD assessment, and so far we’ve seen 65% of patients that are MRD negative at 10 to the minus five at that two-year mark, and about 45% of patients at 10 to the minus six at that two-year mark. So these numbers are improving over time. More and more patients are getting through that threshold. So we’ll see if that MRD negativity is sustained in these patients, and part two is currently enrolling to see whether that randomization to observation versus more therapy will lead to any improvement in some of these outcomes.
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Disclosures
JNJ: Research Funding; Pfizer: Honoraria; Sanofi: Membership on an entity’s Board of Directors or advisory committees; Takeda: Membership on an entity’s Board of Directors or advisory committees, Research Funding; GPCR Therapeutics: Membership on an entity’s Board of Directors or advisory committees; Janssen: Membership on an entity’s Board of Directors or advisory committees, Research Funding; BMS: Membership on an entity’s Board of Directors or advisory committees, Research Funding.
