Disparities in Clinical Trial Populations and the Impact of COVID-19 on Myeloma Care

Sarah Holstein, MD, PhD, discusses the lack of Black patients with multiple myeloma (MM) enrolled in clinical trials, as well as considerations for patient care in the face of the COVID-19 pandemic.

Watch part 1 of the interview with Dr. Holstein where she discusses the MM treatment pipeline.

Watch part 2 of the interview with Dr. Holstein where she discusses targets of interest for MM.

Data has shown that Black patients with multiple myeloma are under-enrolled in clinical trials, and this can impact drugs’ efficacy in this patient population. What are your thoughts on this, and what are some improvements you think can be made to better diversify clinical trial participation?

Dr. Holstein: This is a significant problem in this country, certainly. The vast majority of clinical trials done in this country primarily enroll Caucasians and certainly have very low representation from Blacks and from other ethnic minorities in this country. Therefore, it makes it difficult, because we’re not always sure whether the results that we get on a clinical trial can be appropriately applied to our other patient populations. And so when you’re counseling patients, if they’re somebody who was never represented in the clinical trial, you don’t really know whether the response rates that you’re talking about or the progression-free survival would actually apply to them.

It’s been known for a while that Black individuals have a higher likelihood of developing myeloma, and it’s still not completely understood why. But clearly, as we start to learn more about the biology, there’re been really interesting studies showing that there are differences with respect to myeloma across different patient populations, particularly when white versus Black myeloma patients are examined with respect to what’s actually happening inside their myeloma cell.

For example, there’ve been a couple of reports now that show higher frequencies of t(11;14) in patients’ cells who were Black compared to white. There are other studies, which have shown also discrepancies amongst frequencies for some other cytogenetic abnormalities, and this really suggests that perhaps disease biology might be a bit different between patient populations, which of course would then lead us to suspect that perhaps response to treatments would be different as well.

I think it’s a really difficult question with respect to how we do better. This is a problem not only specific to myeloma, but a problem in this country for all cancer trials. And I don’t have an easy solution. It’s going to require not only sponsors working hard to distribute educational materials, as well as universities and institutions doing as much outreach activities as possible, as well as individual myeloma physicians and nurses and other care providers really getting out into the community to increase awareness about this disease, particularly in the Black population. Myeloma, as you know, is a relatively rare cancer. So oftentimes it’s a cancer that’s not on anybody’s radar, particularly in the Black community. And then there’s just the problem of historically a lot of distrust about the medical community and about clinical trials, in specific. So we really need to do much, much better than we’ve done before. Physicians like Dr. Costa have shown that he can very successfully recruit a large number of Black patients to as clinical trials, and it’s through enormous outreach efforts that he’s done. So all of us need to be doing better, but in addition, there just needs to be a lot of outreach and educational endeavors.

How has COVID-19 impact of care for patients with multiple myeloma?

Dr. Holstein: It’s a great question, and that’s continuing to evolve. When the pandemic first hit and everything was shut down, there was certainly a lot of fear. We didn’t want to increase patients’ risk of dying from COVID-19 by giving them myeloma therapy. Myeloma patients of course are at heart immunocompromised, and this is a disease of plasma cells. So, by definition, patients with myeloma have impaired capabilities of mounting antibody responses to infections. And so this becomes critical when we’re thinking about COVID-19 and the ability of patients to mount effective antibody responses.

So initially there was a lot of fear. A lot of therapies were held because we thought that this would be an initial surge and then the COVID-19 pandemic would hopefully get a lot better, and then we could go back to normal life. Obviously, especially in country, that’s not the case. We have one never-ending wave.

From my own experience, how I’ve counseled patients and how I’ve treated patients has evolved over the last six months. Initially, I was making modifications to therapy, like trying to switch to oral agents if possible or even going sometimes from three drugs down to two drugs if disease seemed to be well controlled. However, as time went on, and again, it became clear that this was not going to be something that was going to be resolved in a short period of time, I’ve really taken the approach of going back to making the myeloma the priority and offering the best possible myeloma treatment. And then at the same time, doing everything possible to try to keep patients safe.

I spent a lot of time, even six months in with my routine follow-up patients, talking about their day-to-day activities and about what activities might be safe from a COVID-19 perspective and what activities might not be safe. There’s a lot of misinformation out in the news, obviously, and a lot of confusion and a lot of mixed messages. So just having consistent messaging from healthcare providers is really important. But ultimately, we initially stopped doing autologous stem cell transplants. We’re back doing that. We’re back giving all the therapies, all the clinical trials, because the myeloma for sure is not going to go away. Eventually, COVID-19 hopefully will, but for patients, myeloma will not. And especially for newly diagnosed patients, we know that what we do in the frontline setting sets the stage for later on, so we don’t want to skimp on therapy early on.

At your institution or you personally, what are some things that you’re doing, some considerations you’re taking to keep patients, yourself, and the care team safe during the pandemic?

Dr. Holstein: The biggest thing that we’re doing right now is utilizing telehealth quite a bit. That has really been able to decrease the number of visits that patients have to make to the hospital or to the clinic setting, decreasing exposure of patients to each other and waiting rooms, decreased exposure of patients to healthcare providers and vice versa in small clinic rooms. I personally have been using quite a bit of telehealth during these times. Frankly, it’s my hope that we can continue to use telehealth moving forward, even after this pandemic is over.

Likewise, I have always been somebody who will very strenuously advocate for vaccinations, but even more now. Flu season just started, flu vaccines are available, so really trying to do everything I can to make sure that all the patients are up to date on their flu, pneumonia, and any other vaccinations.