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.
- 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
