Dr Silbermann on Clinical Trial Design Considerations in Multiple Myeloma

Some communities that will be using [clinical trial] data that we generate may not have the same resources that the academic centers have.”

Rebecca Silbermann, MD, MMS, an associate professor of medicine in the Division of Hematology/Medical Oncology at the School of Medicine of Oregon Health & Science University, discusses key clinical trial design considerations in multiple myeloma, including supportive care measures, end point selection, and enrollment strategies for underrepresented patient populations.

Silbermann discussed several contemporary issues in multiple myeloma management that underscored important considerations for clinical trial design and interpretation across diverse practice settings, which were highlighted at the CoMMit Consortium during the 2025 ASH Annual Meeting and Exposition. She emphasized the need for thoughtful resource allocation when translating trial data into community practice, particularly in centers with fewer supportive care resources than academic institutions. For example, Silbermann pointed to cytokine release syndrome management for patients receiving talquetamab-tgvs (Talvey), noting variability among centers in the use of dexamethasone vs tocilizumab (Actemra) for toxicity mitigation. She suggested that these differences illustrated the importance of designing trials with pragmatic, resource-sensitive supportive care strategies that could be implemented broadly.

Silbermann also reviewed updated recommendations from the International Myeloma Working Group bone subcommittee regarding the use of denosumab in patients with renal impairment. Although the discussion did not substantially alter individual prescribing practices, she noted that it prompted broader consideration of the evolving role of bone-directed therapy in an era of increasingly effective antimyeloma agents.

Additionally, Silbermann described conversations regarding frail patient populations, including French data evaluating dexamethasone-sparing approaches that demonstrated encouraging efficacy. She emphasized that these findings reinforced the need for clinical trials to incorporate patient-centered definitions of success, particularly in vulnerable populations where minimizing toxicity and preserving quality of life may take precedence over achieving minimal residual disease negativity.

Finally, Silbermann addressed emerging data on erythrocyte Duffy genotype and racial disparities in treatment response, noting that the CoMMit group acknowledged substantial remaining knowledge gaps. She concluded that future trial designs must continue to address biologic and sociodemographic disparities to improve equity in myeloma outcomes.