Trial results show significant increase in myeloma patient remission

Press release // 6th December 2016

Data from the largest Phase III trial ever conducted in myeloma have shown a significant, 95%, increase in progression free survival (PFS) in myeloma patients receiving lenalidomide maintenance treatment.

Researchers from the Myeloma XI trial have concluded that the use of maintenance lenalidomide treatment results in highly significant improvements in PFS for patients of all ages, and it should be used as standard care.

This pathway of the trial explored the use of oral lenalidomide taken until disease progression, compared to no maintenance treatment in both newly diagnosed stem cell transplant eligible and transplant non-eligible myeloma patients.

Results demonstrate the efficacy and tolerability of lenalidomide maintenance treatment by showing a median PFS of 37 months, compared to 19 months with no treatment. Lenalidomide maintenance was well tolerated; of those who stopped treatment, only 21.5% did so because of related toxicity, mostly due to neutropenia. 48 cases of second primary malignancy (SPM) were observed in the maintenance group compared to 24 in the no maintenance group.

These are the first results to be presented from the Myeloma XI trial. The data make up one of nine¹ abstracts from the trial being presented at the American Society of Hematology (ASH) Annual Conference.

Myeloma UK Board Director and trial Chief Investigator, Prof Graham Jackson, presented these findings at ASH. He said, “This is a hugely successful trial combining so much hard work and the results are amazing, prolonging average remissions by up to two years.”

This is a hugely successful trial combining so much hard work and the results are amazing, prolonging average remissions by up to two years.

Myeloma UK Board Director and trial Chief Investigator, Prof Graham Jackson

The trial was funded by Cancer Research UK and conducted by the University of Leeds.

Myeloma XI recruited over 4,400 patients across 110 NHS hospitals. It looked at the benefits of different combinations and sequences of treatment in newly diagnosed² myeloma patients focusing on the impact that this had on progression free and overall survival rates.

Dr David Cairns, Principal Statistician at the Leeds Institute of Clinical Trial Research, University of Leeds said, “This is the largest clinical trial conducted in myeloma anywhere in the world.

Approximately 20 per cent of all newly diagnosed patients in the UK since 2010 have participated in it. Being involved in this trial has given these newly diagnosed patients access to drugs that they couldn’t get on the NHS.

Continuous treatment with lenalidomide has been shown to double the average time until relapse – 37 months versus 19 months without treatment. The time to the first disease progression is a surrogate for a patient’s survival from the disease, and so such a big improvement at this stage will hopefully translate to better prognosis. Although we do see a slight increase in the incidence of SPM, we believe the benefits of lenalidomide maintenance far outweigh the risk of SPM”.

Myeloma UK-funded researchers at The Institute of Cancer Research, London (ICR) also played a key role in the trial, conducting novel scientific tests on patient tissue samples in order to better understand the genetic events that occur in myeloma and the consequences they have on treatment response and patient outcomes.

Dr Martin Kaiser leads on scientific and translational studies for the trial and is a Clinical Researcher at the ICR. He presented data at ASH relating to the role of genetic biomarkers for treatment stratification and epigenetic mechanisms in influencing tumour cell behaviour. He said, “The large translational genetics research programme at The Institute of Cancer Research accompanying Myeloma XI will deepen our understanding of the mechanisms driving this disease and provide an evidence base for the design of innovative stratified treatment approaches.”

Myeloma UK Chief Executive Eric Low adds, “It’s fantastic to see data coming out of the Myeloma XI trial. This trial offers the opportunity to further increase our understanding of myeloma and to improve on the current standard of care.

It’s great to see UK research being centre stage at the biggest haematology conference in the world. This trial is a great example of the UK’s capability to do large-scale studies and reinforces the fact that the UK is a great place to do research. Of course none of this would be possible without the participation of patients to whom we owe a huge thanks.”

Dr Áine McCarthy, Cancer Research UK’s Senior Science Information Officer, said: “The results from this large clinical trial could change the way myeloma patients in the UK are treated – they show that patients given lenalidomide after standard treatment survive around a year and a half longer compared with patients who didn’t receive the drug. Around 5,500 people are diagnosed with myeloma each year in the UK, but fewer than one in five survive the disease for 10 years or more. That’s why research like this, which aims to find better treatments, is so important.”

The full abstract can be read here:

Notes to Editors

¹ Myeloma XI abstracts being published at ASH:

  1. Response Adapted Induction Treatment Improves Outcomes for Myeloma Patients; Results of the Phase III Myeloma XI Study. Lead author: Graham Jackson. Oral presentation.
  2. Primary IMiD Refractory Myeloma; Results from 3894 Patients Treated in the Phase III Myeloma XI Study. Lead author: Charlotte Pawlyn. Oral presentation
  3. Impact of Minimal Residual Disease in Transplant Ineligible Myeloma Patients: Results from the UK NCRI Myeloma XI trial. Lead author: Ruth de Tute (presented by Roger Owen). Oral presentation.
  4. Identifying Ultra-High Risk Myeloma By Integrated Molecular Genetic and Gene Expression Profiling. Lead author: Amy Sherborne. Poster presentation.
  5. DNA Methylation Profiling of Myeloma Trial Patients Reveals Specific Epigenetic Changes Associated with Outcome. Martin Kaiser. Oral presentation.
  6. The Impact of Maintenance Lenalidomide on the Mutational Status of the Myeloma Clone at Relapse in the NCRI Myeloma XI Trial for Newly Diagnosed Multiple Myeloma Patients (NDMM). Lead author: John Jones. Poster
  7. Multiple Myeloma with a Deletion of Chromosome 17p: TP53 Mutations Are Highly Prevalent and Negatively Affect Prognosis. Lead author: Davine Hofste op Bruinink. Poster
  8. The Multiple Myeloma Genome Project: Development of a Molecular Segmentation Strategy for the Clinical Classification of Multiple Myeloma. Lead author: Brian A Walker. Oral presentation.

² Myeloma XI looked at the benefits of different combinations and sequences of treatment in newly diagnosed myeloma patients including:

  • How well the combination of Revlimid® (lenalidomide), cyclophosphamide and dexamethasone works in newly diagnosed myeloma patients
  • How well the combination of Kyprolis® (carflilzomib), Revlimid, cyclophosphamide and dexamethasone works in newly diagnosed patients
  • How well the combination of Velcade® (bortezomib), cyclophosphamide and dexamethasone worked in newly diagnosed patients who did not respond well to their initial treatment
  • How well Revlimid only or a combination of Revlimid and Zolinza® (vorinostat) works to stop the myeloma coming back

Myeloma XI was funded by Cancer Research UK, Celgene, Amgen, and Merck & Co Inc. (known outside of the U.S. and Canada as MSD).

Myeloma UK

Myeloma UK is the only organisation in the UK dealing exclusively with myeloma, a cancer for which there is no cure, but many very effective treatments. The charity’s broad and innovative range of services cover every aspect of myeloma from providing information and support, to improving standards of treatment and care through research, education, campaigning and raising awareness. Myeloma UK is passionate and dedicated about what it does and is committed to improving patient outcomes. The organisation receives no government funding and relies almost entirely on voluntary donations and fundraising activities.

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

Cancer Research UK

  • Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
  • Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
  • Cancer Research UK receives no government funding for its life-saving research. Every step it makes towards beating cancer relies on every pound donated.
  • Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last forty years.
  • Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
  • Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
  • Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured.