Eligibility criteria and enrollment of a diverse racial and ethnic population in multiple myeloma clinical trials

•Ineligibility rates were higher among Black patients and racial subgroups classified as Other.•Black patients were more likely to be ineligible for a trial due to failure to meet hematology laboratory criteria. [Display omitted] The narrow eligibility criteria may contribute to the underrepresentation of racial and ethnic subgroups in cancer clinical trials. We conducted a retrospective pooled analysis of multicenter global clinical trials submitted to the US Food and Drug Administration between 2006 and 2019 to support the approval of the use of multiple myeloma (MM) therapies that analyze the rates and reasons for trial ineligibility based on race and ethnicity in MM clinical trials. Race and ethnicity were coded per Office of Management and Budget standards. Patients flagged as having screen failures were identified as ineligible. Ineligibility rates were calculated as the percentage of patients who were ineligible compared with the screened population within the respective racial and ethnic subgroups. Trial eligibility criteria were grouped into specific categories to analyze the reasons for trial ineligibility. Black patients (24%) and other (23%) race subgroups had higher ineligibility rates than White patients (17%). The Asian race 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 other races. Failure to meet disease-related criteria was the most common reason for ineligibility among White (28%) and Asian (29%) participants. Our analysis indicates that specific eligibility criteria may contribute to enrollment disparities for racial and ethnic subgroups in MM clinical trials. However, the small number of screened patients in the underrepresented racial and ethnic subgroups limits definitive conclusions. Kanapuru and colleagues examine the underrepresentation of racial and ethnic subgroups in multiple myeloma clinical trials. The authors report that Black patients and other racial and ethnic subgroups had higher ineligibility rates than White patients. This was partially explained by the failure to meet hematology lab criteria (most likely related to Duffy-null–associated neutrophil count) but also by failure to meet treatment-related criteria (likely related to inadequate access to care for previous first- and second-line th