OP-103 OCEAN Trial: Melflufen in Patients with Multiple Myeloma
Research type
Research Study
Full title
A Randomized, Controlled, Open-Label, Phase 3 Study of Melflufen/Dexamethasone Compared with Pomalidomide/ Dexamethasone for Patients with Relapsed Refractory Multiple Myeloma who are Refractory to Lenalidomide
IRAS ID
205911
Contact name
James Cavet
Contact email
Sponsor organisation
Oncopeptides AB
Eudract number
2016-003517-95
Duration of Study in the UK
4 years, 1 months, 29 days
Research summary
This is a Phase 3 international study investigating an experimental new drug called Melflufen in patients with Multiple Myeloma (MM). The purpose of this study is to compare melflufen + dexamethasone to the approved treatment pomalidomide + dexamethasone. Melflufen is a peptidase potentiated alkylator that works by binding to and damaging DNA, which may stop cells from growing and multiplying. Many peptidases are overexpressed in cancer cells such as tumour cells in MM. Peptidases cleave melflufen to create additional alkylating compounds, including melphalan (Alkeran®) known to be active against MM, so that the concentration of cytotoxic compounds increases preferetially in cancer cells over normal cells. This is expected to result in targeted delivery and better treatment of the disease.
This research study will evaluate the ability of melflufen to treat MM and the associated side effects, in direct comparison with pomalidomide.
To participate in this study, participants must have had prior treatment for MM with a class of drugs called proteasome inhibitors, such as bortezomib (Velcade), carfilzomib (Kyprolis) or ixazomib (Ninlaro), and they must be refractory to their last treatment, which must have included an Immunomodulatory drug called lenalidomide (Revlimid).
There are several parts to this study including: Screening, to determine eligibility; Treatment, which will occur in 4 week treatment cycles until disease progression, unacceptable side effects or withdrawal; and Follow Up, which will last 2 years and require monthly visits until disease progression after which these visits will be every 3 months.
Eligible patients will be randomised to one of 2 treatment groups (melflufen + dexamethasone or pomalidomide + dexamethasone) and will know which treatment group they will be in.
About 450 participants are planned to take part in the study.
This study is sponsored by Oncopeptides AB.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0198
Date of REC Opinion
25 Apr 2017
REC opinion
Favourable Opinion