Black patients with multiple myeloma may not have equitable access to clinical trials of chimeric antigen receptor (CAR) T-cell therapy or bispecific antibodies, according to research published in JAMA Network Open.
Researchers looked at 69 clinical trials of CAR T-cell therapy or bispecific antibodies conducted in the United States and found “limited open sites in states with the highest percentages of Black residents.”
To conduct this study, the researchers searched for all available trials of CAR T-cell therapy or bispecific antibodies listed on ClinicalTrials.gov until January 31, 2022. Studies with 1 or more open sites in the United States were analyzed.
Of the 162 clinical trials found, 69 were included in the analysis. These trials had enrolled or expected to enroll 7896 participants overall, slightly more than half (55.5%) in a CAR-T clinical trial. Most of the trials (96%) were sponsored by industry.
There were 140 clinical trial sites. The mean number of sites per trial was 8.1. Seventeen states (34%) had no open trials for CAR T-cell therapy or bispecific antibodies. According to 2020 Census Bureau data, 35.9% of Black individuals lived in a county with an open CAR-T trial.
Among the 10 states with the highest proportions of Black residents, 6 states had no or fewer than 3 open clinical trials for a CAR T-cell therapy or bispecific antibody. Ten states had 50% or more of their Black population residing in a county with an open trial for CAR T-cell therapy or bispecific antibodies.
“The geographic distribution of clinical trials for CAR-T and bispecific antibodies may be exacerbating disparities in multiple myeloma that Black patients experience,” the researchers wrote.
“The ideal number of Black patients to be enrolled in any clinical trial should aim for a proportion of Black participation that is similar to their proportion in incident multiple myeloma cases. We believe that the lowest acceptable race-specific percentage should be a new bar that clinical trials need to overcome before drug approval.”
Alqazaqi R, Schinke C, Thanendrarajan S, et al. Geographic and racial disparities in access to chimeric antigen receptor-T cells and bispecific antibodies trials for multiple myeloma. JAMA Netw Open. 2022;5(8):e2228877. doi:10.1001/jamanetworkopen.2022.28877