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Improving Equity and Inclusivity in Multiple Myeloma Clinical Research Summary from the MMRF 3rd Annual Health Equity Summit

Hearn Jay Cho, MD, PhD

Anne Quinn Young, MPH

Olamide Banjo, PharmD

This Health Equity and Engagement spotlight highlights the Multiple Myeloma Research Foundation’s (MMRF) commitment to equity in cancer care. Multiple myeloma disproportionately affects Black, Hispanic, and older patients-yet these groups are still underrepresented in clinical trials. Through inclusive trial design, community partnerships, and diverse investigator programs, the MMRF is working to ensure that all patients benefit from research advances. This article shares how the Foundation’s Health Equity Summits and new MMRC Horizon initiative are helping reshape what equitable research looks like populations who are traditionally underserved by the healthcare system and are consistently underrepresented in clinical research. These include racial groups (Blacks and Hispanics) and older adults as the median age of diagnosis is 69 years.

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The mission of the Multiple Myeloma Research Foundation (MMRF) is to accelerate a cure for each and every multiple myeloma patient by focusing exclusively in three areas: supporting the development and delivery of novel therapies; generating, analyzing and sharing large data sets to optimize treatment approaches; and empowering patients and the entire community through education, outreach and support services. Central to our mission is our commitment to advancing health equity so that all myeloma patients can benefit from the scientific and clinical advances we pursue.

As part of this commitment, we believe that clinical trials should reflect the real-world U.S. myeloma patient population so that patients have access to potentially lifesaving treatment options and so that we can understand how these treatments work in all myeloma patients before they receive FDA approval. Unfortunately, certain communities and demographic groups, including patients who are older, who are Black and/or Hispanic, and/or who live in rural areas, are often excluded from multiple myeloma clinical trials. Disparities in access to clinical trials can greatly affect patient outcomes. For example, while Black patients comprise more than 20% of the overall U.S. patient population, they represent less than 5% of clinical trial participants.1 In contrast, through our clinical trials network, the Multiple Myeloma Research Consortium, which comprises nearly 17 sites across the U.S. and Canada, we have consistently enrolled more than 20% Black patients (internal data). Additionally, each year, the MMRF convenes an annual Health Equity Summit to improve equity and inclusivity in multiple myeloma clinical research. The Third Annual Summit, held September 9-10, 2024, in Hyattsville, Maryland, brought together policymakers, academic researchers, biopharma executives, retail pharmacists, Federal regulators and administrators, and community health advocates to explore strategies and solutions to drive proportional patient representation in clinical research studies.

Building on the 2nd Health Equity Summit

Since the 2nd Health Equity

 Summit in 2023, the MMRF made significant strides toward increased inclusivity and access to clinical trials.

In response to research presented by Lauren Merz, MD (Dana-Farber Cancer Institute), which showed that benign laboratory differences disproportionately exclude Black patients from clinical trials2 the MMRF resolved that all future clinical trials conducted by the Foundation through our clinical trials network, the Multiple Myeloma Research Consortium (MMRC), will have more expansive inclusion/exclusion criteria to ensure inclusion of patients who are Duffy-null or have hemoglobinopathies but are otherwise eligible. The MMRC now considers the Duffy-null specific reference range put forth by Merz in developing eligibility criteria and dose-reduction criteria and conducts prospective research within our clinical trials program to refine these factors in the safe conduct of trials to maximize opportunity for the entire myeloma community.

The MMRF has also advanced its Translational Research Umbrella (TRU) program, a new research initiative that will provide deep genomic and immune characterization of patients to better understand how to optimize immune agents. Importantly, TRU will leverage a collaborative network of major medical centers and community sites with diverse patient populations, ensuring sample collection is reflective of a real-world patient population.

As of September 2024, the Foundation launched the MMRC Horizon Clinical Trials Program, an innovative, first-of- its-kind adaptive platform trial program that prioritizes health equity and diversity in its design, site selection, and patient support efforts. MMRC Horizon has appointed a Diversity Officer – Craig Cole, MD (Karmanos Cancer Institute, Detroit, MI) – and established clear enrollment goals of at least 20% Black and 15% Hispanic patients. All MMRC Horizon study sites have a proven track-record of representative clinical trial enrollment and were selected with both geographic and demographic diversity in mind. Additionally, the MMRF is exploring mechanisms to expand Horizon to new community-based sites outside of the MMRC, and will use hub-and-spoke models, community clinics/labs, telemedicine where possible, to support research sites in their efforts to expand access for their patients while reducing the typical burdens associated with clinical trials participation.

In the MMRC Horizon One RRMM study, researchers will prospectively track Duffy status and absolute neutrophil count (ANC), hemoglobin genotypes, and hemoglobin levels for correlation with clinical outcomes, including adverse events, tolerance to therapy/dose reductions, and treatment response. Although MMRC Horizon One will use current standard inclusion and exclusion ranges, supportive care will be allowed prior to screening so that otherwise eligible patients with Duffy-null or hemoglobinopathies will be able to screen and enroll in the trial. To ensure patient burden is not a barrier to participation, the MMRC Horizon team has partnered with Family Reach, a national nonprofit financial resource organization to provide financial assistance with transportation and lodging, meals and utilities.

The 2023 Summit emphasized the importance of patients seeing themselves and their community reflected in their healthcare team. To this end, the MMRF has committed to funding investigators from underrepresented communities through its Scholars Program. The Program’s purpose is to improve equity in myeloma research and overall outcomes by increasing workforce diversity. Two inaugural scholars, Eden Biltibo, MD (Vanderbilt University Medical Center, Nashville, TN), and Joselle Cook, MBBS (Mayo Clinic, Rochester, MN), have since undertaken research focused on eliminating disparities in multiple myeloma outcomes. Dr. Cook’s MAGIC study, for example, aims to determine the prevalence of monoclonal gammopathy of undetermined significance (MGUS) – a precursor condition to multiple myeloma – in Eastern African and Caribbean populations, and identify the frequency and understand the significance of the RS9344 SNP. The community-based study includes site visits to Trinidad, presentations to community advisory boards, discussions with local imams in the Somali community of Rochester, Minnesota, and a series of community outreach materials, including videos and brochures to explain the disease and the study, and its importance to the community.

Leveraging learnings to accelerate progress

Equity in myeloma clinical research is intrinsic to the MMRF’s mission of finding a cure for each and every myeloma patient. The Foundation has integrated key learnings from our Health Equity Summits into our clinical research strategy and we plan to hold our 4th Annual Health Equity Summit later this year

References

  1. Bhatnagar V, Gormley N, Kazandjian D, et al. FDA analysis of racial demographics in multiple myeloma trials. Blood. 2017;130(suppl 1):4352.
  2. Merz L, Hartley-Brown M, Achebe M, Cole C, Kanapuru B, Banjo O, Mulligan G, Wozniak K, Young AQ, Cho HJ. Modernizing multiple myeloma clinical trial eligibility to improve equity and inclusivity by hematological parameters. Semin Hematol. 2024 Oct 25:S0037-1963(24)00125-2.

Hearn Jay Cho, MD, PhD

Clinical Professor of Medicine at the Icahn School of Medicine at Mt. Sinai

Hearn Jay Cho MD, PhD is a Clinical Professor of Medicine at the Icahn School of Medicine at Mt. Sinai and an Attending Physician with the Multiple Myeloma Center of Excellence at the Mt. Sinai Tisch Cancer Institute. Dr. Cho’s laboratory is investigating novel therapies for multiple myeloma. In 2019 Dr. Cho joined the Multiple Myeloma Research Foundation (MMRF) as Chief Medical Officer. Dr. Cho is responsible for the MMRF’s clinical research strategy. Health Equity is a core value of the MMRF mission, and equitable access and participation in MMRF clinical trials are guiding principles. MMRF clinical trials are conducted through the Multiple Myeloma Research Consortium, a group of leading research centers dedicated to advancing treatment options for multiple myeloma patients. Dr. Cho received his MD and PhD in Immunology from Cornell University Medical College (now Weill Medical College), was a resident in the Internal Medicine Investigator Track at UC San Diego Medical Center, and did his clinical fellowship in Hematology and Medical Oncology at New York-Presbyterian Hospital/Weill Cornell Medical Center. He did post-doctoral studies at UCSD and The Rockefeller University in New York City.

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Anne Quinn Young, MPH

Chief Mission Officer at the MMRF

Anne Quinn Young, MPH, is the Chief Mission Officer at the MMRF, leading strategic initiatives to accelerate a cure for multiple myeloma. She oversees education, outreach, and support programs to ensure equitable patient access to high-quality resources and research. Previously, she served as Brand President and Chief Marketing and Development Officer at MMRF. Anne has been recognized in PharmaVoice 100 and contributes to several advisory boards, including the Harvard Business School Kraft Precision Medicine Accelerator. She has co-authored peer-reviewed publications on precision medicine and patient engagement and is a frequent speaker at industry conferences. Since joining MMRF in 2002, Anne has played a key role in launching innovative collaborations that have transformed patient outcomes. She holds a Master of Public Health from Columbia University and a Bachelor of Arts in Government from Dartmouth College.

Olamide Banjo, PharmD.

Senior Director of Community Engagements and Partnerships at the MMRF

Ola Banjo is the Senior Director of Community Engagements and Partnerships at the MMRF, leading efforts to build trust, expand outreach, and improve patient outcomes, focusing on underserved communities. A trained pharmacist, she has developed key partnerships to enhance medication adherence for HIV patients and promote critical vaccinations for high-risk populations. Ola has also created educational materials for patients and healthcare providers and has mentored pharmacy students throughout her career. She holds a Bachelor of Science and Doctor of Pharmacy from Howard University and completed her residency at the University of Illinois at Chicago. A licensed pharmacist in three states, she is active in several professional associations and has contributed to peer-reviewed publications and lectures on health disparities.