The use of end-points other than overall survival (OS) in oncological randomised controlled trials (RCTs) can, under some conditions, reduce the cost and duration of studies. 1 However, the validity of these alternative end-points is not consistently proven in most malignancies, including multiple myeloma (MM), and therefore their widespread use is of concern. 2 Drugs approved by regulatory authorities for MM on the basis of surrogate end-points in Europe and the United States over the last 15 years include carfilzomib, ixazomib, thalidomide, lenalidomide, pomalidomide, liposomal doxorubicin, panobinostat, daratumumab, isatuximab, elotuzumab, 3 selinexor, belantamab mafodotin, ciltacabtagene autoleucel, and idecabtagene vicleucel. 4-6 Some of these agents have gone on to demonstrate an OS benefit in confirmatory registration trials. 7,8

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