The BOTTOM LINE: The Black Swan Research Initiative actively pursues breakthroughs in myeloma research, targeting deep responses, early disease understanding, and developing effective treatments for all myeloma patients.
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This week's "Ask Dr. Durie" comes from a gentleman who wants to know about the IMF's research programs. He's found out about the Black Swan Research Initiative (BSRI) And this question is, what new research is coming out of the BSRI project? To recap, the Black Swan Research Initiative has been ongoing for about ten years now. And the overall summary is that through BSRI, we are creating the science that is needed to develop the cures for all myeloma patients.
One of the most important steps is to be able to track deep responses using minimal residual disease (MRD) testing. And so this was one of the first steps as part of this project. And this is ongoing as a research activity. As far as understanding the science behind of the disease, a key step is to evaluate early disease as part of the iStopMM project.
We are looking at early disease. MGUS monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma, trying to understand the immune changes and the genetic changes that lead to the development of the disease in the first place. And then, the progression from MGUS to smoldering and to active myeloma. The key objective is obviously to understand enough to come up with a treatment that will eradicate myeloma— will create deep responses which are sustained.
And so, two so-called cure trials have been conducted, the CESAR trial in Spain and the ASCENT trial in the US. And these trials have produced remarkably good results. The ASCENT trial, the second trial consists of the use of daratumumab, Kyprolis, REVLIMID, and dex (Dara+KRd), and has produced an 84% MRD-negative rate after two years of therapy.
And so really making great progress towards the goal of moving towards a cure. The key step is obviously to see if that MRD negativity, that apparent eradication of the disease in the bone marrow at this time point is sustained. To make this a practical effort to monitor and assess, it's important to develop accurate, precise, sensitive blood testing that can make it easier for patients to be monitored and assess if MRD negativity is maintained.
In addition, parallel projects using a virtual biobank can be used to study different aspects of the tissue samples that are obtained. And in addition, we are taking information from the immune registry where we can see what is the impact with different immune therapies. The key unmet need, which is a big, big focus for the Black Swan Research Initiative moving forward, is what are we going to do for patients who do not have sustained MRD negativity, who have developed MRD positivity again, or have progressive MRD positivity?
The unmet need is to establish drugs— drug regimens, combinations most likely that will be able to eradicate resistant, MRD positive disease. And so, the BOTTOM LINE is that the Black Swan Research Initiative continues to be a very active project with many laboratory projects, with many clinical projects ongoing with the goal of truly creating the signs that we need to develop cures for all patients with myeloma.
Learn about the International Myeloma Foundation's signature research project.
Professor of Medicine, Hematologist/Oncologist, and Honoree MD at the University of Brussels, Dr. Brian G.M. Durie is a co-founder of the IMF.
