Several studies show that minority patients are not adequately represented in multiple myeloma clinical trials and study inclusion requirements may be a significant part of the problem.
A study published today in Blood says that Black and other racial minority patients have the highest rates of exclusion in trial participation.
The lead author of the study is Bindu Kanapuru, MD, a medical officer with the Food and Drug Administration (FDA). Dr. Kanapuru said:
“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. 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.”
All clinical trials have something called "inclusion criteria." This might include needing to have specific prior treatments, have a minimum number of prior treatments or not have specific health conditions like kidney issues or heart concerns.
In Dr. Kanapuru's study, the group analyzed information from 9,325 patients who were evaluated for enrollment in over 16 clinical trials performed between 2006-2019.
Of patients who were ineligible for the clinical trials:
Black patients were more likely to be excluded because of low blood count levels or not having the minimum number of prior treatments. White patients were more likely to be excluded because they didn't meet the specific disease-related criteria. Other studies in mulitple myeloma show that Black patients are less likely to receive the same "standard of care" treatments than Whites.
Some of this may be just be due to racial genetic differences. Dr. Kanapuru said:
“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. This suggests that trials should set criteria for blood counts that take racial and ethnic variations into account.”
Although Blacks are twice as likely to develop myeloma than whites, less than 5% of clinical trial participants are Black.
Dr. Kanapuru said:
“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,”
The FDA is now requiring pharma companies to include more diverse patients in their clinical trials. Perhaps this means that inclusion criteria for clinical trials needs to change dramatically in order for all patient populations to join, so that we know how a drug could benefit everyone.
about the author
Myeloma survivor, patient advocate, wife, mom of 6. Believer that patients can help accelerate a cure by weighing in and participating in clinical research. Founder of HealthTree Foundation (formerly Myeloma Crowd).
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