Although about 18% of patients with multiple myeloma in the United States are Black, they represent only 4% of clinical trial participants. This article describes why this occurs, what the consequences are, and how this situation can be remedied
This article, published in Blood Advances, describes the demographic representation in multiple myeloma (MM) clinical trials. MM rates are significantly higher among African Americans when compared to White patients, with African Americans exhibiting a rate of 15.8 new cases of MM per 100,000 individuals, compared to only 6.9 among White patients.
Outcomes are also disparate, and this disparity seems to have a complex cause, relating to comorbid conditions, access to care, and disease biology, among other factors. For example, one study in Ghana, quoted by the authors, has found a monoclonal gammopathy rate comparable to that seen in African American populations in the United States, suggesting a possible genetic susceptibility.
The present study relied on clinical trial data submitted to the FDA between 2006 and 2019. Trials that did not collect racial data were excluded from the analysis. The authors associated demographic characteristics (race, ethnicity, and region) with the time-to-event outcomes progression-free survival (PFS) and overall survival (OS) using Cox proportional hazards models, adjusting for age.
In total, 10,157 patients were enrolled in 19 clinical trials during the study period. Three trials included patients with new MM diagnoses, while others included patients with relapsed or refractory MM. Of the patients included, 84% were White, 7% were Asian, and 4% were Black. The survival in Black and Asian patients was numerically longer compared to White patients in the data set.
Black patients represented only 4% of the patients in these studies, despite representing 18% of MM patients throughout the country as a whole. There was a trend toward lower overall response rate (ORR) in Black patients, and an overall better survival rate among Black patients compared to White and Asian patients. The authors note that the rate of Black patients enrolled in these studies is almost five times lower than their rate of incidence of MM, which strongly suggests that studies should target their enrollment in these studies even more, especially as MM afflicts this population group more than any other in the United States.
Reference
Kanapuru, B., Fernandes, L. L., Fashoyin-Aje, L. A., Baines, A. C., Bhatnagar, V., Ershler, R., . . . Gormley, N. (2022). Analysis of racial and ethnic disparities in multiple myeloma US FDA drug approval trials. Blood Adv, 6(6), 1684-1691. https://doi.org/10.1182/bloodadvances.2021005482
