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OCEAN: a randomized Phase III study of melflufen + dexamethasone to treat relapsed refractory multiple myeloma
F. Schjesvold, P. Robak, L. Pour, J. Aschan, P. Sonneveld,
Jazyk angličtina Země Velká Británie
Typ dokumentu protokol klinické studie, časopisecké články
Health & Medicine (ProQuest) od 2005-02-01 do 2020-12-31
Odkazy
PubMed
32141766
DOI
10.2217/fon-2020-0024
Knihovny.cz E-zdroje
- MeSH
- chemorezistence MeSH
- dexamethason terapeutické užití MeSH
- doba přežití bez progrese choroby MeSH
- fenylalanin analogy a deriváty terapeutické užití MeSH
- klinické zkoušky, fáze III jako téma MeSH
- lenalidomid škodlivé účinky MeSH
- lidé MeSH
- melfalan analogy a deriváty terapeutické užití MeSH
- mnohočetný myelom farmakoterapie patologie MeSH
- protokoly antitumorózní kombinované chemoterapie terapeutické užití MeSH
- randomizované kontrolované studie jako téma MeSH
- recidiva MeSH
- thalidomid analogy a deriváty terapeutické užití MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
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
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