Myeloma UK has launched MUK nine, the first UK-wide trial using state-of-the-art genetic techniques to ‘stratify’ treatment for so-called high-risk myeloma patients. The trial aims to identify the best treatment options for high-risk patients, and is one of the first trials, internationally, to focus on this specific sub-group of patients who are in urgent need of better outcomes.
Stratified medicine is a treatment approach that aims to tailor treatment to an individual patient, for example based on their genetic subtype of myeloma. Certain genetic abnormalities are associated with a more active or more difficult to treat myeloma, which is known as ‘high-risk’ myeloma. Patients with high-risk myeloma do not normally respond as well to treatment and are more likely to relapse more quickly.
Patients taking part in the trial will have access to state-of-the-art diagnostics and genetic profiling which has been investigated and developed, in part, through Myeloma UK funded research at The Institute of Cancer Research, London (ICR).
The trial is split into two parts. MUK nine a will see up to 700 newly diagnosed patients screened, by Myeloma UK funded researchers at the ICR, using genetic analysis of their bone marrow samples. Those patients who are identified as being at high-risk will be offered the opportunity to take part in MUK nine b.
MUK nine b is a Phase II trial to assess the effectiveness of the novel treatment combination, bortezomib (Velcade®), lenalidomide (Revlimid®), daratumumab (Darzalex®) and dexamethasone in combination with low dose cyclophosphamide, in conjunction with high-dose therapy and stem cell transplantation.
The trial also aims to increase understanding of the genetic basis of myeloma, and to find disease markers which could be helpful when looking towards developing stratified medicine for other sub-groups of myeloma patients.
Chief Investigator for the MUK nine trial and Senior Researcher at The Institute of Cancer Research, London, Dr Martin Kaiser said, “It’s vitally important that people with myeloma get the most effective treatment for them, particularly people with the highest risk forms of the disease. But we urgently need the evidence to show which therapeutic approaches are right for different groups of patients.
“The MUK nine trial will give patients access to innovative new treatments and state-of-the-art molecular testing. We hope it will transform myeloma treatment from a one-size fits all approach to a stratified approach driven by disease characteristics.”
MUK nine is set to open in 30 Clinical Trial Network (CTN) centres across the UK. It is part of the Myeloma UK CTN, a portfolio of early stage trials developed, co-ordinated and sponsored by the Clinical Trials Research Unit at the University of Leeds, which aims to test and speed up access to promising new treatments for patients.
Myeloma UK Director of Research Dr Simon Ridley added, “Around 20% of myeloma patients are characterised as having high-risk myeloma, yet there is relatively little research looking at high-risk disease and treatment. This trial is looking to the future – we are trying to gain more insight into which treatment combinations might work best in different groups of patients.
“It also offers patient access to novel combination treatments that they cannot currently get access to through the NHS. The data this trial will generate can be used in the UK and beyond to support patient access to the most innovative and effective combination treatments.”
Myeloma UK is funding MUK nine with both funding support and drugs provided by Celgene UK & Ireland (lenalidomide) and Janssen Oncology (daratumumab). Skyline Dx’s prognostic tool, MMprofiler, will be used in combination with other genetic prognostic tools to risk-stratify patients on this trial.
Find out more about our clinical trials, visit our dedicated webpage. Or to learn more about myeloma and its treatments call the Myeloma Infoline free from the UK on 0800 980 3332 or email AskTheNurse@myeloma.org.uk.