Melflufen is a novel peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. It has emerged as a potential new multiple myeloma treatment, particularly for late-stage forms of the disease. Here we describe the rationale and design of OCEAN (NCT03151811), a randomized, head-to-head, superiority, open-label, global, Phase III study evaluating the efficacy and safety of melflufen + dexamethasone versus pomalidomide + dexamethasone. Eligible patients with relapsed refractory multiple myeloma have received 2-4 previous treatments and are refractory to both lenalidomide and their last treatment. Patients are excluded if they have previously received pomalidomide. The primary endpoint is progression-free survival, and key secondary endpoints include overall response rate, duration of response and overall survival.

Erasmus MC Cancer Institute and Erasmus University of Rotterdam Rotterdam The Netherlands

Medical University of Lodz Lodz Poland

Oncopeptides AB Stockholm Sweden

Oslo Myeloma Center Oslo University Hospital and KG Jebsen Center for B Cell Malignancies University of Oslo Oslo Norway

University Hospital of Masaryk Brno Czech Republic

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Melflufen: A Peptide-Drug Conjugate for the Treatment of Multiple Myeloma