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Daratumumab (dara) has been shown to have single-agent activity in relapsed or refractory myeloma. To test its role in combination regimens, investigators conducted two industry-sponsored, multicenter, phase III trials comparing the doublets of lenalidomide plus dexamethasone (len/dex) with or without dara and bortezomib plus dexamethasone (bor/dex) with or without dara in previously treated patients with relapsed or refractory myeloma. The primary endpoint of each study was progression-free survival (PFS).
Dimopoulos and colleagues randomized 569 patients to receive len/dex with or without dara. In a prespecified interim analysis at a median 13.5 months of follow-up, disease progression or death occurred in fewer patients receiving dara wit…