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

J 2020

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

SCHJESVOLD, F., P. ROBAK, Luděk POUR, J. ASCHAN, P. SONNEVELD et. al.

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

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

Odkazy

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

Změněno: 12. 3. 2021 14:14, Mgr. Tereza Miškechová

Anotace

V originále

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.

Citovat

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.

@article{1751716,
   author = {Schjesvold, F. and Robak, P. and Pour, Luděk and Aschan, J. and Sonneveld, P.},
   article_location = {London},
   article_number = {11},
   doi = {http://dx.doi.org/10.2217/fon-2020-0024},
   keywords = {alkylating agent; melflufen; MM; multiple myeloma; Phase III study; relapsed refractory multiple myeloma; RRMM},
   language = {eng},
   issn = {1479-6694},
   journal = {Future Oncology},
   title = {OCEAN: a randomized Phase III study of melflufen plus dexamethasone to treat relapsed refractory multiple myeloma},
   url = {https://www.futuremedicine.com/doi/10.2217/fon-2020-0024?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed},
   volume = {16},
   year = {2020}
}

TY  - JOUR
ID  - 1751716
AU  - Schjesvold, F. - Robak, P. - Pour, Luděk - Aschan, J. - Sonneveld, P.
PY  - 2020
TI  - OCEAN: a randomized Phase III study of melflufen plus dexamethasone to treat relapsed refractory multiple myeloma
JF  - Future Oncology
VL  - 16
IS  - 11
SP  - 631-641
EP  - 631-641
PB  - Future Medicine Ltd.
SN  - 14796694
KW  - alkylating agent
KW  - melflufen
KW  - MM
KW  - multiple myeloma
KW  - Phase III study
KW  - relapsed refractory multiple myeloma
KW  - RRMM
UR  - https://www.futuremedicine.com/doi/10.2217/fon-2020-0024?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed
N2  - 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.
ER  -

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. \textit{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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