Current eligibility criteria may be a hurdle to diversity in multiple myeloma trials, according to a recently published study led by FDA researchers.

The study, a retrospective pooled analysis published in Blood, looked at 16 multisite, global trials submitted to FDA between 2006-2019 in support of novel multiple myeloma treatments. Researchers from CDER and the Oncology Center of Excellence analyzed data for 9,325 patients screened for enrollment to understand why and to what degree different races and ethnicities were deemed ineligible for participation.

A majority (83 percent) of the patients were White, while seven percent were Asian, four percent were Black or of unknown race, and two percent were of “other” races, including American Indian, Alaska Native, Native Hawaiian and other Pacific Islanders. Four percent of patients reported Hispanic ethnicity.

In total, 17 percent of the 9,325 patients had been found ineligible for enrollment, with ineligibility rates differing by racial and ethnic groups. Black patients saw the highest ineligibility rates (24 percent), followed by “other” races (23 percent), White patients (17 percent), and finally Asian patients (11 percent).

Inadequate blood cell counts and failure to meet treatment-related criteria, including receiving specific treatments and a minimum number of treatments prior to the trial, were the most frequent reasons for ineligibility amongst Black patients, the study found. White and Asian patients were most likely to be ruled ineligible for not meeting specific disease-related criteria.

One important finding, the researchers said, was that a subset of Black patients made it into trials despite failing to meet certain eligibility criteria, including low blood counts.

“This suggests that some physicians may already be factoring in racial and ethnic variations in things such as blood counts when they evaluate patients for trial eligibility,” Bindu Kanapuru, first author of the study and a medical officer with CDER, said. “While this is encouraging, the actions of individual physicians are unlikely to be enough to solve the problem of racial and ethnic disparities in trial enrollment.”

These findings should not be considered definitive, the researchers cautioned, citing the small number of underrepresented patients included in the analysis.

Access the full study findings here: https://bit.ly/3nDQK9z.