Enrollment criteria for multiple myeloma trials may exclude racial, ethnic minorities
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Key takeaways:
- Patients from most underrepresented groups had higher ineligibility rates than white patients.
- Black patients appeared more likely not to meet hematology lab and protocol-specified treatment-related criteria.
Parameters established to determine who can enroll in clinical trials for new multiple myeloma treatments may contribute to underrepresentation of certain racial and ethnic minorities, according to data published in Blood.
Current eligibility criteria tended to cause a higher percentage of patients who identified as Black and as “other” race to be deemed ineligible, whereas those identifying as white and Asian had lower ineligibility rates.
“Our study suggests that, in multiple myeloma clinical trials, some eligibility criteria specified in trial protocols may be contributing to racial and ethnic disparities in enrollment,” Bindu Kanapuru, MD, medical officer with FDA Center for Drug Evaluation and Research, said in a press release. “We found that, compared with white patients, those who were Black or of other races (American Indians, Alaska Natives, Native Hawaiians and other Pacific Islanders) were more likely to be deemed ineligible for trial enrollment.”
Background and methodology
Restrictive eligibility criteria may contribute to underrepresentation of racial and ethnic subgroups in cancer clinical trials, according to study background.
Such underrepresentation has been cause for concern particularly in trials related to multiple myeloma, which disproportionately affects African Americans. Although they have twice the incidence of multiple myeloma as white individuals in the U.S., African Americans currently make up less than 5% of patients enrolled in multiple myeloma clinical trials.
In an effort to evaluate the rates and reasons for trial ineligibility by race and ethnicity in these trials, researchers conducted a retrospective pooled analysis of 16 multicenter, global clinical trials submitted to the FDA between 2006 and 2019 to support approval of multiple myeloma therapies. The trials included 9,325 patients evaluated for enrollment, 17% of whom had been deemed ineligible for participation.
Researchers calculated ineligible rates as a percentage of patients deemed ineligible compared with the screened population within the respective racial and ethnic subgroups.
Results, next steps
Black (25%) and other (24%) race subgroups had higher ineligibility rates compared with the white subgroup (17%), with individuals identified as Asian having the lowest ineligibility rate (12%).
Among Black patients, failure to meet hematologic lab criteria (19%) and failure to meet treatment-related criteria (17%) appeared to be the most common reasons for ineligibility, compared with failure to meet disease-related criteria for Asian (29%) and white (28%) participants.
The analysis indicated that certain eligibility criteria may be a reason for enrollment disparities for certain racial and ethnic subgroups, specifically in multiple myeloma clinical trials, according to the researchers.
“The very small numbers of minority patients who were evaluated makes it impossible for us to draw definitive conclusions,” Kanapuru said in the release. “However, we hope that our study will raise awareness of this issue.”
References:
- Criteria for selecting who can enroll in multiple myeloma clinical trials may exclude patients from racial and ethnic minorities (press release). Available at: www.eurekalert.org/news-releases/987870. Published May 4, 2023. Accessed May 4, 2023.
- Kanapuru B, et al. Blood. 2023;doi:10.1182/blood.2022018657.
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Kanapuru B, et al. Blood. 2023;doi:10.1182/blood.2022018657.
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