OCEAN: a randomized Phase III study of melflufen + dexamethasone to treat relapsed refractory multiple myeloma
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.
|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|
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