Eligibility Criteria required for enrollment in multiple myeloma (MM) clinical trials may contribute to racial and ethnic disparities, according to a study published in the Blood Journal.
Although Black individuals are 2 times more likely than their White counterparts to be diagnosed with MM, they comprise less than 5% of those enrolled in clinical trials intending to lead to the approval of new treatments.
For this study, Bindu Kanapur, MD, and colleagues analyzed the rates and reasons for trial ineligibility by race and ethnicity in MM clinical trials.
“To our knowledge, this is the first study to evaluate trial eligibility criteria as a potential barrier to the enrollment of patients from underrepresented racial and ethnic subgroups into clinical trials for multiple myeloma,” said Dr. Kanapuru.
The study included 9325 patients evaluated for enrollment in 16 clinical trials of novel MM treatments performed between 2006 and 2019.
The researchers found that those who were Black or of other races were more likely than White patients to be deemed ineligible for trial enrollment.
The study population was 83% White, 7% Asian, 4% Black, and 2% were defined as other races (including American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders).
The research team observed that 17% of evaluated patients were ineligible for trial enrollment. The ineligibility rate was highest for Black patients (24%), followed by those of ‘other races’ (23%). 17% of White patients were deemed ineligible, while Asian patients had the lowest ineligibility rate (11%).
Black patients were often deemed ineligible due to low blood cell counts or lack of prior specific treatments. In contrast, White and Asian patients were often ineligible for not meeting disease-related criteria.
“Previous studies in patients with multiple myeloma have shown that ‘normal’ levels of neutrophils (a type of white blood cell) may be lower among Black patients than whites and that Black patients have higher rates of anemia (a shortage of red blood cells) than whites,” Dr. Kanapuru said. “This suggests that trials should set criteria for blood counts that take racial and ethnic variations into account.”