Podrobný výpis o publikaci

SCHJESVOLD, F., P. ROBAK, Luděk POUR, J. ASCHAN a 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, roč. 16, č. 11, s. 631-641. ISSN 1479-6694. Dostupné z: https://dx.doi.org/10.2217/fon-2020-0024.

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Základní údaje
Originální název	OCEAN: a randomized Phase III study of melflufen plus dexamethasone to treat relapsed refractory multiple myeloma
Autoři	SCHJESVOLD, F., P. ROBAK, Luděk POUR (203 Česká republika, domácí), J. ASCHAN a P. SONNEVELD (garant).
Vydání	Future Oncology, London, Future Medicine Ltd. 2020, 1479-6694.

Další údaje
Originální jazyk	angličtina
Typ výsledku	Článek v odborném periodiku
Obor	30204 Oncology
Stát vydavatele	Velká Británie a Severní Irsko
Utajení	není předmětem státního či obchodního tajemství
WWW	URL
Impakt faktor	Impact factor: 3.404
Kód RIV	RIV/00216224:14110/20:00118378
Organizační jednotka	Lékařská fakulta
Doi	http://dx.doi.org/10.2217/fon-2020-0024
UT WoS	000527676700003
Klíčová slova anglicky	alkylating agent; melflufen; MM; multiple myeloma; Phase III study; relapsed refractory multiple myeloma; RRMM
Štítky	14110212, rivok
Příznaky	Mezinárodní význam, Recenzováno
Změnil	Změnila: Mgr. Tereza Miškechová, učo 341652. Změněno: 12. 3. 2021 14:14.

Anotace
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.

Anotace

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.