Clinical trials are a critical part of drug development in myeloma and have led to the approval and use of nearly 20 new agents in myeloma over the last 20 years. I often think of the major advances in myeloma as being the 4 “Ts” — Triplets (drug combinations), Transplant (stem cell transplants), CAR T-cell therapy, and Clinical Trials. Sadly, however, all these four forms of therapy have been less accessible to certain populations, namely African American and Latino American patients. This inequity is unacceptable.
The IMF has worked very hard to reduce health disparities in multiple ways, specifically through its M-Power program. The program is built on three pillars of community: ENGAGEMENT, primary care EDUCATION, and patient care ENHANCEMENT.
To enhance patient care, the IMF’s M-Power program promotes greater access to therapy, including clinical trials. These trials are designed to help patients; yet historically, clinical trials in myeloma lack representation of diverse populations.
Many groups, in particular African Americans and Latino Americans, have had less access to clinical trials. While African Americans represent approximately 20% of all patients with myeloma in the U.S., only 5-8% of these patients have taken part in clinical trials.1 This number is even lower in “pivotal” trials that have led to drug approval. While clinical trials are designed to help patients, we must consider how these trials can be designed to help ALL patients.
Underrepresentation of African America and Latino Americans in clinical trials in myeloma is a problem on many levels. It sadly reflects a failed strategy to engage all communities, speaks to the greater issues of health disparities based on race and socio-economic status, and reveals the shortcomings of aspects of our healthcare system. The result is deeply concerning: It reveals that while many could benefit from trials, they do not.
Furthermore, it reduces the value of the trials to others. Without appropriate representation of people from all backgrounds in clinical trials, how can we conclude that the results of these trials will apply to all patients? For example, we are learning with novel immunotherapies such as CAR T-cell therapy and bispecific antibodies, differences in the side effects and the efficacy of these agents may vary according to the race and ethnicity of the patients who receive them. In fact, recent evidence demonstrates that Cytokine Release Syndrome (CRS) is more common in the Hispanic American population.2
This is a complex problem that requires a complex solution. All stakeholders must be involved: government, the Food and Drug Administration (FDA), industry, academic centers, investigators, health-care teams, patient organizations, the public, and underrepresented communities. The IMF regularly works with all these entities to tackle this problem.
I would like to share with you one group that I had the privilege to meet with recently — a group of myeloma and lymphoma doctors who are supporters of the DRIVE initiative.
DRIVE is an acronym for a strategy to ensure greater diversity in clinical trials and stands for:
D: Diversity officer for clinical research studies
R: Ranking of clinical studies for diversity
I: Individual diversity, equity, inclusion, and access plan
V: Verification of study diversity
E: Elevate and enhance the training of minority investigators and research team members.3
Dr. Ruemu Birhiray (an oncologist in Indianapolis) and his team have conducted this initiative. As the DRIVE model and tool is being validated, he convened a key group of myeloma and lymphoma doctors at a meeting in Maui to express their desire to increase diversity in clinical trials by signing the Declaration of Maui. This document reflects the commitment of these doctors, and many more, to do all they can to support the principles of DRIVE. The wording of the declaration section was simple:
Accomplishing this will take time, effort, resources, and dedication. I am very proud that the IMF is committed to ALL patients with myeloma and is a supporter of the Declaration of Maui. Stay tuned for more information about our strategy to increase diversity in clinical trials in the coming month.
— IMF Chief Medical Officer Dr. Joseph Mikhael, aka “Dr. Joe”
ABOUT JOSEPH MIKHAEL, MD, M.Ed.
Dr. Joseph Mikhael is a world-renowned multiple myeloma expert. In his position with the IMF, he works to advance the mission of the organization in research, education, advocacy, and patient care to improve the lives of patients with myeloma. Dr. Mikhael has conducted dozens of clinical trials in the field of multiple myeloma and has contributed to the development of many novel drugs. He has served as a Professor of Medicine at the Mayo Clinic, an Associate Dean at the Mayo Clinic School of Graduate Medical Education, and as the Deputy Director of Education at the Mayo Clinic Cancer Center. Dr. Mikhael also serves as a counselor on the American Society of Hematology (ASH) Executive Committee and is involved in mentoring the next generation of hematologists. He did his medical training in Canada, having completed medical school at the University of Ottawa, his hematology training at the University of Toronto, and a Multiple Myeloma Fellowship at Princess Margaret Hospital. He also has a master’s degree in education from the University of Toronto. Dr. Mikhael remains in clinical and academic medicine with the City of Hope Cancer Center in California. Visit Dr. Joseph Mikhael’s full biography
