Posted: Friday, August 18, 2023
Despite the disproportionate effects of multiple myeloma on non-White populations, the underrepresentation of racial and ethnic minority groups in myeloma clinical trials is the subject of new research published in the journal Blood. Bindu Kanapuru, MD, of the U.S. Food and Drug Administration (FDA), Bethesda, Maryland, and colleagues found clinical trial ineligibility rates were higher among Black patients and patients whose race was classified as other and narrow eligibility criteria may contribute to these disparities. The researchers noted specifically that Black patients were more likely to be ineligible as a result of failing to meet hematology laboratory criteria, and they recommended considering racial differences in laboratory values when defining eligibility. In addition, they suggested a need for broad stakeholder collaboration when designing trials to address patient- and system-level barriers that may influence trial enrollment.
“Restrictive eligibility criteria are an important barrier to the enrollment of patients in cancer clinical trials,” the investigators noted. “Although lower enrollment rates of racial and ethnic minority groups in multiple myeloma clinical trials are well documented, there are limited data regarding eligibility criteria as a barrier to enrollment.”
The study consisted of a retrospective pooled analysis of multicenter global clinical trials of multiple myeloma therapies submitted to the FDA between 2006 and 2019. Patient demographics, eligibility status, and reasons for trial ineligibility were collected and standardized in the pooled data set. Ultimately, 16 trials were included, comprising a total of 9,325 patients.
In their analysis, the investigators found that Black patients (24%) and those classified as other (23%) had higher ineligibility rates than White patients (17%). Asian patients had the lowest ineligibility rate (12%) among all racial subgroups. Failure to meet the hematologic laboratory criteria (19%) and treatment-related criteria (17%) were the most common reasons for ineligibility among Black patients and were more common in Black patients than in those of other races.
Disclosure: For full disclosures of the study authors, visit ashpublications.org.