Most multiple myeloma studies do not address 'elephant in the room'
Improving representation of African American patients in multiple myeloma research is essential to preventing outcome disparities in this population, according to a spotlight session at ASH Annual Meeting and Exposition.
“The incidence of multiple myeloma in African Americans is two- to threefold higher and mortality is more than double compared to Caucasians,” Srinivas S. Devarakonda, MD, associate professor of hematology at The Ohio State University, said. “They comprise 20% to 22% of the population with multiple myeloma, yet their representation in clinical trials is less than 5%. It is dismal.”
Poor relatability
Devarakonda said the underrepresentation of African American patients in clinical trials and genomic studies has been a long-term oversight and one that has gone unaddressed for far too long.
“We’ve been extrapolating the data from studies involving mainly Caucasians to African Americans for a long, long time, and that explains the outcome disparities,” he said. “It’s become an elephant in the room — we know this population’s incidence and mortality is high, but we don’t pay enough attention to it. We’ve just gotten used to ignoring it.”
This avoidance is hardly benign, Devarakonda added, because it translates to drugs and cellular therapies being investigated, approved and used in standard clinical practice without being tested in a population that is disproportionately affected by multiple myeloma.
“You could question the validity or relatability of these results in this particular population,” he said.
Likewise, there is a need for greater participation of African American patients in genomic studies of multiple myeloma, Devarakonda said.
“There are studies that show that the biology of multiple myeloma in African Americans is different from Caucasians,” he said. “There is a need to study the biology and genomic makeup of multiple myeloma in greater detail in African Americans, but how are we going to get accurate data without their representation?”
Barriers to accrual
Understanding the barriers to accrual for African American patients is essential to improving representation in clinical trials and genomic studies, Devarakonda said. The reasons for poor accrual are manifold and exist at the patient, provider and institutional levels, he added.
Devarakonda cited geographic location as a major barrier to clinical trial access.
“In the states, cities and counties where African Americans predominantly live, there is a huge lack of clinical trial options,” he said. “In some states, there are no clinical trial site openings, and in some of the states, there are less than three openings for the whole state.”
Implicit or unconscious bias on the part of providers is another challenge to adequate enrollment of African American patients in multiple myeloma trials, Devarakonda said.
“Physicians may think that African Americans would not be interested in clinical trials, or they might assume that they wouldn’t be adherent,” he said.
Clinical trial eligibility criteria also frequently exclude African American participants, Devarakonda said, especially lab-based criteria. These criteria often fail to consider race-specific changes in the reference ranges for a certain race or ethnicity.
“For example, African Americans tend to have low neutrophil counts at baseline,” he said. “When you use a higher reference range for the normal value for the absolute neutrophil count, many of the African American patients become ineligible for clinical trials.”
Patient suspicion of the medical system and specifically of clinical trials is another major obstacle to optimal accrual of African American patients, Devarakonda said.
“There is a lot of mistrust and fear based on things that have happened in the past,” he said. “They don’t have faith in the consent forms — they think the consent forms are meant to protect the doctors and the hospitals.”
A path forward
Devarakonda said the increased awareness of health care disparities in recent years has been accompanied by major efforts by medical societies and organizations such as ASH, American Association for Cancer Research, ASCO, American Society for Transplant and Cellular Therapy (ASTCT) and International Myeloma Foundation. These organizations have launched diversity, equity and inclusion initiatives focused on improving access to novel drugs and cellular therapies, as well as improving clinical trial enrollment.
Devarakonda stressed the need to also reach out to underrepresented groups in the communities where they live.
“We should collaborate with community-based oncologists and local cancer support organizations to open clinical trials at community cancer centers where most African Americans receive their care,” he said. “We will probably be more successful trying to bring the clinical trials to patients, rather than trying to bring the patients to clinical trials.” Training for clinicians about implicit and explicit bias — as well as cultural competency training — is also essential to making large-scale improvement in clinical trial enrollment, Devarakonda said. Increasing diversity in clinical staff is another valuable step in improving racial concordance between providers and patients, he added.
“It’s been shown that if the provider who is offering a clinical trial to a patient belongs to the same race or ethnicity as that patient, the chance of them consenting for the clinical trial is higher,” he said. “It also creates a better environment when you have cultural racial diversity.”
Devarakonda emphasized the importance of redesigning multiple myeloma clinical trials to implement eligibility criteria that is more inclusive of African American patients.
“We need to revisit some of the inclusion criteria we’ve been following without much scientific evidence,” he said. “We need to take into consideration the racial differences in the normal values of labs, as well as the higher incidences of comorbidities.”
To ensure more equitable representation of African American patients in clinical trials, Devarakonda noted that requirements should be implemented for enrollment.
“FDA should mandate a certain percentage of African Americans in each clinical trial that is submitted for approval of a certain drug,” he said. “Even journals that accept manuscripts for publication need to mandate reporting of race and ethnicity in their research studies to facilitate robust data collection.”
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Efebera YA, et al. Tackling greater burden of multiple myeloma in African American patients. Presented at: ASH Annual Meeting and Exposition, Dec. 9-12, 2023; San Diego.
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