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High-risk multiple myeloma (MM) represents an area of significant unmet medical need, as patients who fall under this umbrella continue to experience poor outcomes, despite therapeutic advances in recent decades. In a critical step toward addressing this gap, the IMS, in collaboration with the International Myeloma Working Group (IMWG), developed a consensus definition of high-risk MM that reflects the latest available evidence on prognostic factors and treatment outcomes.
Entitled “International Myeloma Society/International Myeloma Working Group Consensus Recommendations on the Definition of High-Risk Multiple Myeloma,” the peer-reviewed article, published online on June 09, 2025 in the Journal of Clinical Oncology (JCO®), provides critical and timely guidance for clinicians, researchers, clinical trial sponsors, patients, advocates, and other stakeholders, serving as a clear and concise roadmap for identifying high-risk disease in patients with MM.
"Treatments for MM have come a long way, and the innovative therapies and combination regimens introduced over the past two decades have significantly extended survival. But patients with high-risk disease represent a group with persistently poor prognosis, despite receiving modern treatments. While most standard-risk patients can expect to have an overall survival that exceeds 10 years, high-risk disease is associated with progression within 2 years and short overall survival, in the range of 4 to 5 years," said Dr. Nikhil C. Munshi, Immediate Past President of the IMS and Director of Basic and Correlative Science, Jerome Lipper Multiple Myeloma Center, at the Dana-Farber Cancer Institute, and Kraft Family Chair and Professor of Medicine at Harvard Medical School in Boston, Massachusetts, USA. Dr. Munshi, the corresponding author of the paper, added, "The IMS-IMWG consensus definition provides more than just a compilation of high-risk features. Our intention is to facilitate the design and conduct of clinical trials focused on patients with high-risk disease, to foster the development of safe and effective therapies and, ultimately, to improve patient prognosis."
Currently, there is a lack of uniformity in how high-risk MM is defined across clinical trials. While other MM risk stratification models are available, previously published schemes do not all reflect contemporary evidence for the prognostic impact of key genomic/cytogenetic risk features and/or improvements in outcomes with modern treatments. Moreover, patients with MM placed in the same risk category based on prior risk stratification models have widely varying survival. The risk markers, assessment methods, and cutoffs used for defining high-risk disease differ between stratification schemes, which can make it difficult for clinicians to apply the schemes uniformly in practice.
"This JCO® publication underscores the importance of collaboration in the myeloma community, spearheaded by the IMS. The discourse and debate at the 2023 IMS Genomics Meeting and subsequent discussions made it possible to develop consensus," said Prof. Philippe Moreau, current IMS President and Head of the Hematology Department at the University Hospital of Nantes, France. Dr. Moreau, a co-author on the paper, added, "This publication represents a core tenet of the IMS’ mission, bridging evidence and expertise to advance myeloma care for all patients.”
“Cancer therapy is increasingly omics-driven and genomic assessments, especially next-generation sequencing, informs treatment decisions across hematology/oncology practice. The consensus genomic staging put forth in this publication integrates, for the first time in the MM space, sequencing-based assessment into risk characterization. We encourage all myeloma clinicians and researchers, as well as hematology/oncology providers who care for and treat patients with myeloma, to access the paper and apply the definition going forward,” Dr. Munshi said.
About The International Myeloma Society
The International Myeloma Society (IMS) is a professional, scientific, and medical society established to bring together clinical and experimental scientists involved in the study of multiple myeloma and plasma cell dyscrasias. With over 1,000 members from 60 countries, the IMS represents a truly global myeloma community committed to Research, Advocacy, Clinical care, and Education—the RACE to cure myeloma. IMS members include myeloma thought leaders from across the globe, representing major multiple myeloma cooperative groups in different world regions, basic research scientists, clinical investigators in the field, physicians, clinical trainees, and other healthcare practitioners.
Moira Hancock
International Myeloma Society
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