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.

Basic information

Original name

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

Authors

SCHJESVOLD, F., P. ROBAK, Luděk POUR (203 Czech Republic, belonging to the institution), J. ASCHAN and P. SONNEVELD (guarantor)

Edition

Future Oncology, London, Future Medicine Ltd. 2020, 1479-6694

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30204 Oncology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 3.404

RIV identification code

RIV/00216224:14110/20:00118378

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.2217/fon-2020-0024

UT WoS

000527676700003

Keywords in English

alkylating agent; melflufen; MM; multiple myeloma; Phase III study; relapsed refractory multiple myeloma; RRMM

Abstract

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 and 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, vol. 16, No 11, p. 631-641. ISSN 1479-6694. Available from: 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 and 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, vol.~16, No~11, p.~631-641. ISSN~1479-6694. Available from: https://dx.doi.org/10.2217/fon-2020-0024.

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