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PRESS RELEASE: Myeloma UK launches first UK-wide stratified medicine trial

Press release // 10th October 2017

10 October 2017 – Myeloma UK has launched MUK nine, the first UK-wide molecularly stratified myeloma trial. The trial aims to identify the best treatment options for high risk myeloma 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.

Hosted by the Clinical Trials Research Unit at the University of Leeds, MUK nine will deliver on the aspirations set out in the recent Life Sciences: industrial strategy¹ 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. Internationally, there is much interest in genomic approaches from both drug developers and regulators.

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 (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 b¹.

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 an autologous stem cell transplant².

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 stratified medicine that benefits all 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.”

Chief Investigator for the MUK nine trial and Senior Researcher at The Institute of Cancer Research, London, Dr Martin Kaiser

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 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 currently available in a restricted setting on the NHS, to patients in Scotland. SkylineDx’s prognostic tool, MMprofiler, will be used in combination with other genetic prognostic tools to risk-stratify patients on this trial.

Notes to Editors

¹ Life Sciences: industrial strategy https://www.gov.uk/government/publications/life-sciences-industrial-strategy

² Samples from the Phase II trial will be analysed by the Haematological Malignancy Diagnostic Services, University of Leeds and the Clinical Immunology Service, University of Birmingham, to understand if this novel treatment combination works in newly diagnosed, high risk myeloma patients.

About the Myeloma UK Clinical Trial Network

The Myeloma UK Clinical Trial Network aims to gain better understanding of the treatments or combination of treatments that are best for patients at different stages of myeloma, and to look at how new treatments may be made available to patients in the UK.

It also seeks to address these questions with data from a portfolio of early-phase myeloma trials. These trials are coordinated by the Clinical Trials Research Unit at the University of Leeds, and delivered through the expertise and resources of over 30 hospitals throughout the UK.

The CTN currently has seven trials in its portfolio.

About Myeloma UK – www.myleoma.org.uk

Myeloma UK is the only organisation in the UK dealing exclusively with myeloma – our ultimate goal is to find a cure.

We are dedicated to ensuring that patients get access to the right treatment at the right time, and to improving standards of treatment and care through research, education and awareness raising. Our organisation also provides a range of information and support services to patients, family and friends to help deal with a diagnosis of myeloma.

Myeloma UK receives no Government funding and relies almost entirely on voluntary donations and fundraising.

University of Leeds

The University of Leeds is one of the largest higher education institutions in the UK, with more than 31,000 students from 147 different countries, and a member of the Russell Group research-intensive universities.

We are a top 10 university for research and impact power in the UK, according to the 2014 Research Excellence Framework, and positioned as one of the top 100 best universities in the world in the 2015 QS World University Rankings. We are The Times and The Sunday Times University of the Year 2017 www.leeds.ac.uk.

The Institute of Cancer Research, London, is one of the world’s most influential cancer research organisations.

Scientists and clinicians at The Institute of Cancer Research (ICR) are working every day to make a real impact on cancer patients’ lives. Through its unique partnership with The Royal Marsden NHS Foundation Trust and ‘bench-to-bedside’ approach, the ICR is able to create and deliver results in a way that other institutions cannot. Together the two organisations are rated in the top four centres for cancer research and treatment globally.

The ICR has an outstanding record of achievement dating back more than 100 years. It provided the first convincing evidence that DNA damage is the basic cause of cancer, laying the foundation for the now universally accepted idea that cancer is a genetic disease. Today it is a world leader at identifying cancer-related genes and discovering new targeted drugs for personalised cancer treatment.

A college of the University of London, the ICR is the UK’s top-ranked academic institution for research quality, and provides postgraduate higher education of international distinction. It has charitable status and relies on support from partner organisations, charities and the general public.

The ICR’s mission is to make the discoveries that defeat cancer. For more information visit http://www.icr.ac.uk