Eligibility Criteria in Multiple Myeloma Clinical Trials May Lead to Racial Disparities

Eligibility criteria in multiple myeloma (MM) clinical trials may contribute to enrollment disparities for certain racial and ethnic subgroups, according to research published in Blood.

Black patients are more frequently found to be ineligible for these trials than White or Asian patients, and are more likely to be excluded for failing to meet lab or treatment-related criteria, researchers found.

In this retrospective analysis of clinical trials that were submitted to the US Food and Drug Administration in 2006-2019 in support of approval for an MM indication, researchers examined criteria associated with patient ineligibility, as well as rates of ineligibility across racial and ethnic subgroups.

A total of 16 trials and 9325 patients were included. Most patients (83%) were White, 7% were Asian, 4% were Black, 4% were of unknown race, and 2% were categorized as “other,” which included American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander. Ethnicity was listed as Hispanic for 4% of patients, not Hispanic for 71%, and unknown for the remaining 25%.

Overall, 17% of patients were deemed ineligible for trial. The trial ineligibility rate was also 17% for White patients. For Black patients, the rate of ineligibility was 24%, and for patients classified as “other,”  the rate of ineligibility was 23%. Asian patients had an ineligibility rate of 11%.

Trial ineligibility among Black patients was most commonly attributed to a failure to meet protocol-specific hematologic lab criteria (19%) or a failure to meet treatment-related criteria (17%). For White patients, these rates were 10% and 12%, respectively.

Patients who were White (28%) or Asian (29%) were most frequently considered ineligible for failing to meet disease-related criteria. Disease-related criteria was also the most common reason for ineligibility among both Hispanic (21%) and non-Hispanic (27%) patients.

“Our analysis of MM clinical trials suggests that certain protocol specified eligibility criteria may contribute to racial and ethnic disparities in enrollment onto MM clinical trials,” the researchers concluded. “Given the multiple factors that may contribute to the underrepresentation of racial and ethnic groups in clinical trials, broad stakeholder collaboration to address other factors, in addition to broadening eligibility criteria, will be needed to address disparities.”

Disclosures: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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. Published online May 4, 2023. doi:10.1182/blood.2022018657