MUK Nine b: Optimum
Research type
Research Study
Full title
MUK nine b: OPTIMUM. A phase II study evaluating multiple novel agentsoptimised combination of biological therapy in newly diagnosed high risk multiple myeloma and plasma cell leukaemia.
IRAS ID
215490
Contact name
Martin Kaiser
Contact email
Sponsor organisation
Univeristy of Leeds
Eudract number
2016-002670-12
ISRCTN Number
ISRCTN16847817
Duration of Study in the UK
5 years, 0 months, 31 days
Research summary
Multiple myeloma is a disorder of plasma cells which accumulate in the bone marrow. It is the second most common haematologic cancer in the EU, causing about 21,000 deaths in the EU in 2008.
Approximately 20% of patients with myeloma have an extremely poor survival of less than 3 years and these patients are characterised as having high risk (HR) disease.
There have been no improvements in outcome over the last decade for patients with HR disease. However recent data has shown that combination of multiple novel agents is potentially better and therefore in this phase II trial we wish to evaluate whether we can improve the outcomes for high risk patients by using multiple biological agents during treatment over a number of stages.
The primary objective of this trial is to look at whether a combination of four novel agents bortezomib (Velcade), lenalidomide (Revlamid) dexamethasone & Daratumumab(darzalex) with cyclophosphamide is active in a high risk patients, to take forward into a phase III trial compared to standard treatment.
Approximately 560 participants with myeloma will need to be registered for screening at diagnosis in order to include 95 high risk participants in the MUK nine b:Optimum Protocol.
REC name
London - South East Research Ethics Committee
REC reference
17/LO/0023
Date of REC Opinion
26 Jan 2017
REC opinion
Favourable Opinion