Expanding Treatment Access
Numerous studies have found that African American patients, as well as other minority patient groups, are less likely to receive new classes of MM therapies, such as immunomodulatory drugs and proteasome inhibitors.4
Dr Anderson thinks part of the reason could be the underrepresentation of African Americans in clinical trials. For example, if trials are not carried out in predominantly African American neighborhoods, “we don’t have communities of patients [participating in clinical trials who] would also promote that awareness and access.”
In addition, even though physicians are very likely not consciously avoiding novel MM therapies for African American patients in clinical practice, they may hesitate to prescribe these drugs because clinical trials did not test them in patients with comorbidities such as kidney disease that are common among African American patients, said Michael Rosenzweig, MD, MS, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, California. On the other hand, “studies that specifically target minority populations, and African American patients specifically, will pique physicians’ interest when they are evaluating these patients,” noted Dr Rosenzweig, who was not involved in the recommendations. Dr Rosenzweig is conducting research to compare the ability of leflunomide to delay the progression of high-risk, smoldering MM in African American and White patients.
Dr Rosenzweig thinks the new recommendations were smart to be separated into preapproval and postapproval settings. Although drug sponsors generally want to study medications in populations with few comorbidities prior to approval, they may be more willing to broaden eligibility criteria once the drug has been registered, he explained. Nevertheless, Dr Rosenzweig said that he is not aware of many postapproval clinical studies of MM therapies. The article noted that incentives could be provided for drug sponsors to carry out costly postapproval studies that focus on pertinent racial groups, as is the case for pediatric and orphan drugs.
A Call to Action
There is no question as to the need to greatly increase representation of African American patients in MM clinical trials, said Scarlett Lin Gomez, MPH, PhD, professor of epidemiology and biostatistics at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center. “We see this underrepresentation regardless of which cancer, and quite honestly it is not even specific to cancer,” Dr Gomez said. The disparity is a particular travesty, she added, because of known health inequities among African Americans.
Although these are not the first recommendations for improving racial representation in cancer clinical trials, Dr Gomez noted that they are fairly specific in terms of enumerating the actions that should be taken and that could strengthen their impact. However, even with the best intentions among drug sponsors and other stakeholders, there are competing priorities, and real change may not happen unless it is mandated. Dr Gomez said that a big step in this direction could be if the FDA were to require drug sponsors to justify the racial composition of the proposed study in their clinical trial application, thus before they have authority to conduct the trial.
It may be easier for certain hospitals and cancer centers to conduct inclusive clinical trials. For example, Dr Anderson and many of the authors of the recommendations work at National Cancer Institute-Designated Cancer Centers, which are required to have a diversity office that conducts community outreach and engagement and helps with study enrollment to ensure it is representative of the local population. Nevertheless, Dr Gomez thinks any medical center could prioritize these activities. Ultimately, she added, there should be “one overall package” that includes enrolling and retaining patients in clinical trials, as well as just getting patients through the door and connecting them with the most appropriate treatment.
The new recommendations are really just the beginning, Dr Anderson said. “I think of the article as really a call to action, as the first step in what I hope will be a process that will not only result in accrual of African Americans into clinical trials at these various settings but also will improve the new drug development paradigm more generally,” he said.
- Bhatnagar V,Gormley N, Kazandjian D, et al. FDA analysis of racial demographics in multiple myeloma trials. Blood. 2017;130(Suppl1):4352. doi:10.1182/blood.V130.Suppl_1.4352.4352
- Gormley N, Fashoyin-Aje L, Locke T, et al. Recommendations on eliminating racial disparities in multiple myeloma therapies: a step toward achieving equity in healthcare. Blood Cancer Discov. 2021;2:119-124. doi:10.1158/2643-3230.BCD-20-0123
- Waxman AJ, Mink PJ, Devesa SS, et al. Racial disparities in incidence and outcome in multiple myeloma: a population-based study. Blood. 2010;116(25):5501-5506. doi:10.1182/blood-2010-07-298760
- Ailawadhi S, Parikh K, Abouzaid S, et al. Racial disparities in treatment patterns and outcomes among patients with multiple myeloma: a SEER-Medicare analysis. Blood Adv. 201;3(20):2986-2994. doi:10.1182/bloodadvances.2019000308