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; J. ASCHAN a P. SONNEVELD

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

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/20:00118378

Organizační jednotka

Lékařská fakulta

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://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 = {https://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://doi.org/10.2217/fon-2020-0024.

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