In pivotal trials testing daratumumab in patients with transplant-ineligible newly diagnosed multiple myeloma, inadequate crossover provisions have not only compromised the interpretation of survival data but also left fundamental questions about optimal treatment sequencing unanswered. Herein, we address the ethical implications of trial designs that fail to guarantee access to effective post-progression therapy for patients in the control arm, particularly in studies across regions in which standard-of-care treatment varies dramatically.
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G.R.M. declares that his institution has received research funding from Janssen for a phase III trial of which he is a site principal investigator, although he did not receive any personal payments or salary support from Janssen for this trial. A.M.G. declares no competing interests.
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Mohyuddin, G.R., Goodman, A.M. Daratumumab and missed sequencing opportunities in transplant-ineligible multiple myeloma: lessons for future trials. Nat Rev Clin Oncol 22, 539–540 (2025). https://doi.org/10.1038/s41571-025-01034-w
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DOI: https://doi.org/10.1038/s41571-025-01034-w
