FDA Evaluates Multiple Myeloma Trial Enrollment Disparities in Racial, Ethnic Subgroups

A recent analysis suggests that “specific eligibility criteria may contribute to enrollment disparities for racial and ethnic subgroups” in clinical trials for multiple myeloma (MM).

Bindu Kanapuru, MD, of the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA), and colleagues conducted the research and published their findings in Blood.

They conducted a retrospective pooled analysis of multicenter global clinical trials that submitted data to the US FDA to support approval of a therapy for an MM indication between 2006 and 2019.

Dr. Kanapuru and colleagues analyzed the rates and reasons that patients were deemed ineligible for MM clinical trials. They defined ineligibility rates as the percentage of patients who were ineligible compared to the screened population within their respective racial and ethnic subgroups.

Nearly one-quarter (24%) of patients who were Black, and 23% of patients who were classified as belonging to an “other” racial or ethnic subgroup were deemed ineligible for an MM clinical trial. Those groups had higher ineligibility rates compared with patients who were White (17%) and those who were Asian (12%). Patients who were Asian had the lowest ineligibility rates among racial subgroups.

Not meeting hematologic lab criteria (19%) and not meeting treatment-related criteria were the most common reasons for trial ineligibility among patients who were Black and were more common in patients who were Black. Not meeting disease-related criteria was the most common reason for trial ineligibility among patients who were White (28%) or Asian (29%).

“Our analysis indicates that specific eligibility criteria may contribute to enrollment disparities for racial and ethnic subgroups in MM clinical trials,” Dr. Kanapuru and colleagues wrote. “However, the small number of screened patients in underrepresented racial and ethnic subgroups limits definitive conclusions.”

They also outlined the FDA’s plans for addressing enrollment disparities.

“The FDA guidance recommends sponsors developing medical products to prospectively define a plan that includes but [is] not limited to enrollment goals for underrepresented racial and ethnic study population[s] and study design features that will allow for an assessment of safety and effectiveness during the entire clinical development of the product,” Dr. Kanapuru and colleagues concluded.

Reference

Kanapuru B, Fernandes L, Baines AC, et al. Eligibility criteria and enrollment of a diverse racial and ethnic population in multiple myeloma clinical trials. Blood. 2023. doi:10.1182/blood.2022018657