New recommendations aim to eliminate racial bias in myeloma trials

February 18, 2021

Researchers from Dana-Farber Cancer Institute, the U.S. Food and Drug Administration (FDA) and the American Association for Cancer Research (AACR) are releasing recommendations designed to address the under-representation of African Americans in clinical trials for multiple myeloma (MM), a blood cancer that is twice as deadly in this demographic as in whites.

The initiative, publishing today in the AACR journal Blood Cancer Discovery, is a "road map" for designing myeloma clinical trials to eliminate racial bias by including more African American patients, as well as gathering "real-world" data from health records about the effects of drugs in African American patients. Through this joint workshop initiated by the FDA and AACR, a cohort of researchers, physicians, patients, statisticians, the pharmaceutical industry and regulators reviewed existing issues with the goal of improving effectiveness of MM therapies in African Americans.

Multiple myeloma is diagnosed in about 30,000 people in the United States annually, resulting in more than 12,500 deaths. African Americans are more than twice as likely as whites to be diagnosed with myeloma - 15.9 vs 7.5 cases per 100,000 population - and to die from the disease - 5.6 vs 2.4 myeloma deaths per 100,000 for African Americans compared with whites.

Although the disease is not presently curable, an array of new treatments in recent years has generally improved outcomes for myeloma patients. It is concerning, however, that data from large multiple myeloma clinical trials shows a decrease in enrollment of African Americans by 3.5% over a recent 10-year period, and even more critically, most racial and ethnic minority patients participated in trials that did not involve novel agents."There hasn't been as much progress in African Americans as there has been in other groups," says Dana-Farber Cancer Institute's Kenneth C. Anderson, MD, the corresponding author of the study and program director of the Lebow Institute for Myeloma Therapeutics and the Jerome Lipper Multiple Myeloma Center. "The number of African Americans enrolled in clinical trials of novel agents or treatments of multiple myeloma has been tragically low. When they have enrolled, their outcome to treatment with novel therapies has been the same or even better than other patients," he said.

African Americans comprise 20% of people diagnosed with myeloma, but between 2003 and 2017 only 4.5% of patients in new drug and biological license applications for myeloma were African American. This disparity has raised concerns that the findings of therapeutic clinical trials may not be entirely valid for African Americans, due to underlying genetic and biological differences that have been discovered between African American and white myeloma patients.

The new recommendations emerged from a February 2020 workshop in Washington D.C. which was co-chaired by Nicole Gormley, MD and Lola Fashoyin-Aje MD, MPH from the FDA, as well as Anderson, who heads the Regulatory Science and Policy Subcommittee of the AACR. The group recommended a number of changes to the design of clinical trials of drugs for which manufacturers are seeking approval. They included: Other recommendations concerned gathering clinical trial data in the post-approval period. Studies conducted after the drug has entered clinical use could identify differences among racial and ethnic subpopulations with regard to safety and efficacy.

The recommendations also seek to increase diversity by directing stakeholders to devise strategies to overcome clinical, social, and socioeconomic impediments to trial access.

Anderson emphasized the importance of myeloma patients' participation in the workshop that formulated the recommendations.

"Our patients are truly the inspiration and heroes of this collaborative effort to eliminate the glaring issue of racial disparities in clinical trials," he said. "If we can make clinical trials more inclusive and representative of real-world patients, we may not only enhance participation of African American patients, but also provide a paradigm for new drug development more broadly."

Dana-Farber Cancer Institute

Related Kidney Disease Articles from Brightsurf:

Waistline matters in kidney disease
Does fat matter in kidney disease? The investigators found that all measures of higher abdominal fat content (including visceral fat, liver fat, or subcutaneous fat) and slower walk times were associated with increased levels of cardiometabolic risk factors in adults with non-dialysis dependent kidney disease.

Reducing urinary protein for patients with rare kidney disease slows kidney decline
New findings show that reducing the amount of protein in the urine of patients with focal segmental glomerulosclerosis can significantly slow declines in kidney function and extend time before patients' kidneys fail.

Antioxidant agent may prevent chronic kidney disease and Parkinson's disease
Researchers from Osaka University developed a novel dietary silicon-based antioxidant agent with renoprotective and neuroprotective effects.

Acute kidney injury and end stage kidney disease in severe COVID-19
Many COVID-19 patients experience hematuria, proteinuria and elevated serum creatinine concentration early in the course of the disease.

Genes tell a story about diabetic kidney disease
Studying Finnish genes leads to unique revelations about the development of a serious complication of diabetes, and informs an ongoing genomic study of a Singaporean cohort as part of Singapore's Diabetes Study in Nephropathy and other Microvascular Complications (DYNAMO).

New study provides insight into chronic kidney disease
Researchers have further analyzed a known signaling pathway they believe brings them one step closer to understanding the complex physiology of patients with chronic kidney disease (CKD), which might provide a path to new treatment options.

Predicting risk of chronic kidney disease
Data from about 5 million people (with and without diabetes) in 28 countries were used to develop equations to help identify people at increased five-year risk of chronic kidney disease, defined as reduced estimated glomerular filtration rate (eGFR).

A healthy diet may help prevent kidney disease
In an analysis of published studies, a healthy dietary pattern was associated with a 30% lower incidence of chronic kidney disease.

Is kidney failure a man's disease?
A new analysis of the ERA-EDTA Registry [1] reveals a striking gender difference in the incidence and prevalence of end-stage renal disease.

Chronic kidney disease: Everyone's concern
850 million people worldwide are affected by kidney disease. This worrying figure was published last June.

Read More: Kidney Disease News and Kidney Disease Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to