Daratumumab and missed sequencing opportunities in transplant-ineligible multiple myeloma: lessons for future trials

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.