IMS 2024 | Increasing diversity in myeloma clinical trials: addressing disparities & inclusion criteria

So when we do clinical trials on myeloma, really in cancer medicine, it’s important that we have an inclusion of minorities, ethnicities, ages, genders, in order to make sure that the drugs that we use are applicable across the board and not just one specific group. And this highlights some of the data from three, actually three different bispecific trials that specifically looked at the response rates and the toxicities of bispecifics in patients that are black living around the world and then African Americans living in the US. You know, a couple of things. One is, again, the importance of having diverse populations in clinical trials because as As is in the US with the FDA, although 5% of black patients were included on the trials that got some of these drugs approved by the FDA, it ends up there’s actually 20, 21% African Americans in the United States with myeloma. So, there’s a terrible disparity. For Hispanics, about 88% of myeloma patients are Latino, but only 1-2% are involved in clinical trials. And when you look at patients who are over the age of 85 or in their high 80s, again, single number digits for inclusion in clinical trials. So when these drugs are approved by the FDA, and they have such small numbers of these different groups included, then how can I be certain that these drugs will actually work for those groups? The other thing is solutions. How do we improve upon enrollment of these clinical trials? One is inclusion and exclusion criteria. The FDA also looked at screen failures and ineligibility rates for, again, trials that were registered with the FDA for approval. They found that actually blacks and Hispanics were more likely to screen fail and to not be eligible for clinical trials than their white counterparts. And for blacks, it was because of hematologic criteria. So the inclusion exclusion criteria that we write on clinical trials that we have cut and pasted over the years and years actually can be exclusionary to black patients because there’s something known as the Duffy Null Phenotype or what used to be called the neutropenia of ethnicity that normally and naturally people of African descent, about 67, 68% of people of African descent will have lower neutrophil counts. It doesn’t offer any particular risk of infection, but if you set your bar for your inclusion criteria to say that the neutrophil count has to be over two, and naturally a black person has a neutrophil count of 1.5, despite anything else, they’re going to be excluded from those clinical trials. And so rewriting and being thoughtful about how we do clinical trials is important to be more inclusionary. And also other solutions as well, such as decentralizing the clinical trials that we have. So instead of having you know minority patients and patients from socioeconomic status that may be a little bit lower we should go to them and go to their neighborhoods and to go to the cancer doctors that they see every day and deploy our clinical trials to the populace, because that that’s where the people are, sometimes people don’t want to go to some big academic center. Some of the clinical trials are now being written. So, the DETERMINATION trial that was written, that was RVd transplant versus no transplant. The HORIZON trial, which is coming up in the United States, which is a multi-prong, evergreen trial that’s coming up, have built-in parameters and have built-in inclusion/exclusion criteria around the Duffy null phenotype and actually will adjust for that. So patients are tested for the Duffy status, for the Duffy null, and everything shifts down a bit, which then includes them, and therefore that’s better.