OCEAN: a randomized Phase III study of melphalan flufenamide + dexamethasone to treat relapsed refractory multiple myeloma

Future Oncology
Fredrik SchjesvoldPieter Sonneveld

Abstract

Melphalan flufenamide (formerly 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 melphalan flufenamide + 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 end point is progression-free survival, and key secondary endpoints include overall response rate, duration of response and overall survival.

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Citations

Sep 15, 2020·Expert Opinion on Investigational Drugs·Albert OriolPaul G Richardson
May 22, 2020·Expert Opinion on Investigational Drugs·Luca BertaminiSara Bringhen
Oct 1, 2020·Journal of Clinical Medicine·María-Victoria MateosPaul G Richardson
Jul 25, 2020·Haematologica·Annamaria Gulla, Kenneth C Anderson
Dec 10, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Paul G RichardsonUNKNOWN HORIZON (OP-106) Investigators
Feb 23, 2021·Frontiers in Oncology·Gregory P Kaufman, Claudio Cerchione
Oct 16, 2020·Haematologica·Annamaria Gulla, Kenneth C Anderson
May 8, 2021·Drugs·Sohita Dhillon
Jun 3, 2021·Cancers·Fredrik Schjesvold, Albert Oriol
Jul 16, 2021·Drug Design, Development and Therapy·Fortunato MorabitoMassimo Gentile

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Methods Mentioned

BETA
xenograft
electrophoresis
contraception

Clinical Trials Mentioned

NCT01897714
NCT02963493
NCT03481556
NCT03639610
NCT04115956
NCT03151811
NCT01311687

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