Image: Dispensing medicines for a clinical trial. Credit: Jan Chlebik for the ICR, 2014
People with newly diagnosed high risk myeloma will be treated based on the results of genetic testing as part of a new UK-first clinical trial.
The evidence from the trial, launched today by Myeloma UK, will help doctors move from a “one-size-fits-all” approach to treating myeloma to one that is more targeted to specific patient groups.
The MUK nine trial is one of the first trials of its kind in the world and experts predict it could transform myeloma treatment on the NHS and in healthcare systems around the world.
The trial will deliver on the aspirations set out in the recent Life Sciences: industrial strategy which calls for the UK to lead innovation in clinical trial methodology, and to embed routine genomic analysis to make trials more targeted and effective.
High risk myeloma patients make up around 20% of all people with myeloma and generally have a worse prognosis than other patients. More evidence is required to ensure that high risk myeloma patients get access to the best possible treatments.
MUK nine has been designed to address this evidence gap, and to incorporate genetic tests as a way of identifying this group of patients, a process which is also known as stratified medicine.
Access to state of the art diagnostics
Hosted by the Clinical Trials Research Unit at the University of Leeds, patients taking part in the trial will have access to state of the art diagnostics and remission profiling which has been investigated and developed, in part, through Myeloma UK-funded research at The Institute of Cancer Research, London.
Up to 700 newly-diagnosed patients will be recruited and screened by genetic analysis of their bone marrow samples. This analysis is conducted by Myeloma UK-funded researchers at The Institute of Cancer Research (ICR). Those patients who are identified by the genetic analysis as being of high risk will be then offered a chance to take part in MUK nine.
MUK nine is a Phase II trial to assess the effectiveness of a new treatment combination in conjunction with an autologous stem cell transplant: bortezomib (Velcade®), lenalidomide (Revlimid®), daratumumab (Darzalex®) and dexamethasone in combination with low dose cyclophosphamide will be used to treat these newly diagnosed, high risk myeloma patients.
Daratumumab is currently only available in a restricted setting on the NHS, to patients in Scotland. so the results of this trial could quickly affect access to the treatment.
The trial also aims to increase understanding of the genetic basis of myeloma in general, and to find disease markers which could be helpful when looking towards stratified medicine that benefits all myeloma patients.
Transforming myeloma treatment
Chief Investigator for the MUK nine trial and Senior Researcher at the ICR, 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 one driven by disease characteristics.”
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Speeding up access to promising new treatments
MUK nine will initially open in 35 Clinical Trial Network (CTN) centres across the UK. It is part of the Myeloma UK CTN, a portfolio of early stage trials 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 high risk patients.
“It also offers patient access to novel combination treatments that they cannot currently get access to through routine commissioning. 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).
Daratumumab is a novel monoclonal antibody that is not currently available for use on the NHS. Skyline Dx’s prognostic tool, MMprofiler, will be used in combination with other genetic prognostic tools to risk-stratify patients on this trial.
This article was adapted from the original press release by Myeloma UK.