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.

Additional Metadata
Keywords alkylating agent, melflufen, MM, multiple myeloma, Phase III study, relapsed refractory multiple myeloma, RRMM
Persistent URL dx.doi.org/10.2217/fon-2020-0024, hdl.handle.net/1765/126209
Journal Future Oncology
Citation
Schjesvold, F. (Fredrik), Robak, P. (Pawel), Pour, L. (Ludek), Aschan, J, & Sonneveld, P. (2020). OCEAN: a randomized Phase III study of melflufen + dexamethasone to treat relapsed refractory multiple myeloma. Future Oncology, 16(11), 631–641. doi:10.2217/fon-2020-0024