MONDAY, May 8, 2023 (HealthDay News) — Eligibility criteria may contribute to racial and ethnic disparities in enrollment in multiple myeloma (MM) clinical trials, according to a study published online May 4 in Blood.
Bindu Kanapuru, M.D., from the U.S. Food and Drug Administration in Silver Spring, Maryland, and colleagues examined the rates and reasons for trial ineligibility by race and ethnicity in MM clinical trials in a pooled analysis of multicenter global clinical trials submitted to the FDA between 2006 and 2019 to support approval of MM therapies.
The researchers found that compared with Whites, Blacks and other race subgroups had higher ineligibility rates (25 and 24 percent, respectively, versus 17 percent); among the racial subgroups, Asian race had the lowest ineligibility rates (12 percent). The most common reasons for ineligibility among Blacks were failure to meet hematologic lab criteria and failure to meet treatment-related criteria (19 and 17 percent, respectively); these reasons were more common for Blacks than other races. Among White and Asian participants, failure to meet disease-related criteria was the most common reason for ineligibility (28 and 29 percent, respectively).
“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,” Kanapuru said in a statement. “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.”
One author disclosed financial ties to COTA Healthcare.
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