SCHJESVOLD, F., P. ROBAK, Luděk POUR, J. ASCHAN and P. SONNEVELD. OCEAN: a randomized Phase III study of melflufen plus dexamethasone to treat relapsed refractory multiple myeloma. Future Oncology. London: Future Medicine Ltd., 2020, vol. 16, No 11, p. 631-641. ISSN 1479-6694. Available from: https://dx.doi.org/10.2217/fon-2020-0024.
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Basic information
Original name OCEAN: a randomized Phase III study of melflufen plus dexamethasone to treat relapsed refractory multiple myeloma
Authors SCHJESVOLD, F., P. ROBAK, Luděk POUR (203 Czech Republic, belonging to the institution), J. ASCHAN and P. SONNEVELD (guarantor).
Edition Future Oncology, London, Future Medicine Ltd. 2020, 1479-6694.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30204 Oncology
Country of publisher United Kingdom of Great Britain and Northern Ireland
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 3.404
RIV identification code RIV/00216224:14110/20:00118378
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.2217/fon-2020-0024
UT WoS 000527676700003
Keywords in English alkylating agent; melflufen; MM; multiple myeloma; Phase III study; relapsed refractory multiple myeloma; RRMM
Tags 14110212, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 12/3/2021 14:14.
Abstract
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.
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