The Black Swan Research Initiative Moves Ever Closer to a Cure for Myeloma
Thinking Outside of the Box to Conquer Multiple Myeloma
How the IMF’s Black Swan Research Initiative Is Changing the Way We Approach Multiple Myeloma.
Six years ago, the original team, led by IMF Chairman Brian G.M. Durie, MD, concluded that the only way to cure the disease was to be able to identify it – and treat it vigorously – before it was too late. Flash forward, and the BSRI has made tremendous progress, with more than 50 sites around the world where investigators are implementing MRD testing into their clinical trials.
“We can talk about the potential for curing myeloma, because we are so close, and we feel that we are, in fact, already most likely curing patients in the cure trials. We have ideas and ways to expand the percentage of patients who are curable, which is just truly remarkable.” - Dr. Brian G.M. Durie.
Learn more about the Black Swan Research Initiative and how the IMF approaches finding the cure for myeloma on the IMF's Road to the Cure.
Dr. Joseph Mikhael: The Black Swan Research Initiative (BSRI) is a worldwide collaboration to find a cure for multiple myeloma. It brings together the expertise of individuals, individual institutions, even countries together in a way that they could never be partners otherwise.
IMF Founder and President Susie Durie: If we were going to cure multiple myeloma we had to bring together people who were brilliant in this area and who were willing to work together collaboratively to find out what it's going to take to finally put an end to this disease.
Dr. S. Vincent Rajkumar: The whole Black Swan Research Initiative is predicated on a premise that we may need to think out of the box if we are going to conquer multiple myeloma.
Dr. Brian G.M. Durie: To see if we could come close to curing myeloma, it was essential to be able to accurately and reproducibly measure the amount of myeloma present at a very, very low level of disease -what we call minimal residual disease, MRD. And so, the first requirement was to have available sensitive testing for MRD. And so, the first project was to develop a very sensitive and accurate MRD testing with a flow cytometry method, and this has rolled out on a global basis. Now we have over 50 sites around the world where investigators are implementing MRD testing into clinical trials.
Dr. Joseph Mikhael: The Black Swan Research Initiative brings together these modalities in a unifying way to be able to use MRD status to truly impact patient care.
Dr. Brian G.M. Durie: The ultimate step in this aspect will be the approval by the FDA for MRD as an endpoint to assess the value of one treatment versus another within a clinical trial. And, it moved rather quickly from the idea of needing an MRD test and then identify the correct setting to use the best therapies available. And so, the second decision was to start therapy in patients with very early disease, and we focused on what is called high-risk smoldering myeloma and those are patients defined as a population who do not have active myeloma but are predicted to develop the act of myeloma within 12 to 18 months.
Dr. S. Vincent Rajkumar: Myeloma has long remained a disease that has not been curable and the thinking was is that because we didn't have effective drugs or is it because we are employing these effective drugs when it is already too late?
Dr. Brian G.M. Durie: And so, there was a requirement to accurately identify such high-risk smoldering myeloma patients.
Dr. S. Vincent Rajkumar: Right now, the only way you know that you have asymptomatic myeloma is if somebody happens to find it. So, how do we find this disease if no one's looking for it? So, we have an effort in Iceland looking at screening strategies. And then the next step, which we have already launched, is a trial that seeks to cure myeloma, and the innovative part of the trial is that it applies the best available therapy that we have for multiple myeloma to early asymptomatic patients with high-risk smoldering myeloma. This trial is called the ASCENT trial and it's already accruing.
Dr. Joseph Mikhael: If our ultimate goal is a cure, then we need cure trials. Trials that have an endpoint of genuine cure, where we can fashion it beyond an individual drug or set of drugs and put it into a system that includes the diagnostic skills that we have around the world, the therapeutic skills to find a path towards that cure.
Dr. Brian G.M. Durie: There has been tremendous progress right now, we have over 25 Black Swan research projects going forward. So, in this span of six years, we can talk about the potential for curing myeloma because we are so close, and we feel that we are already most likely curing these patients in these trials. And, we have ideas and ways to expand that percentage of curable patients. It is just truly remarkable, and we can see the next horizon, where we will see what is achievable with the very promising new immunotherapies.
IMF Founder and President Susie Durie: We're in this because we believe that we can work collaboratively and we will cure this disease once and for all.