Trial confirms dual benefits of drug for multiple myeloma

Multiple myeloma cross section

Professor J Anthony Child and Professor Walter M Gregory (Clinical Trials Research Unit (CTRU), University of Leeds), Professor Gareth J Morgan (formerly at the University of Leeds), together with colleagues from universities and NHS Trusts across the UK, compared two different types of bisphosphonate drug in patients with multiple myeloma.

They found that zoledronic acid improved survival in these patients when compared against the UK and European standard treatment of clodronic acid (sodium clodronate). This improvement was independent of the drug’s ability to prevent skeletal-related injures, showing that zoledronic acid has treatment benefits beyond bone health.

These findings from the Medical Research Council (MRC) Myeloma IX study are published online and in an upcoming Lancet, and are being presented at the American Society of Hematology meeting in Orlando, Florida.

Patients with advanced cancer are given bisphosphonates as part of their standard care to help prevent their bones from becoming weakened. In multiple myeloma, malignant plasma cells in the bone marrow can induce bone destruction, putting patients at high risk of fractures.

Previous work has suggested that some bisphosphonates, including zoledronic acid and clodronic acid, may also destroy cancer cells as well as protecting patients’ bones. Zoledronic acid, in particular, was singled out in these early trials. However, no consensus has been reached on its use in standard care regimens for symptomatic multiple myeloma patients.

In this study, the authors compared the effects of two biophosphonates – zoledronic acid and clodronic acid – in a randomised trial. The trial involved 1960 multiple myeloma patients at 120 different UK centres, making it the largest and most comprehensive myeloma trial to date.

The researchers found that zoledronic acid reduced mortality by 16% versus clodronic acid, and extended median overall survival by 55 months (50 months versus 44.5 months). Both bisphosphonates were generally well tolerated by the patients.

“The improvement in overall survival with zoledronic acid, which remained significant after adjustment for the reduction in risk of skeletal-related events, adds to the growing clinical evidence supporting anticancer benefits with zoledronic acid in patients with newly diagnosed cancers,” the authors said.

“Although we have not definitively identified the underlying mechanism of action, the early improvement in overall survival with zoledronic acid compared with clodronic acid supports early use of zoledronic acid in multiple myeloma,” they concluded.

For more information:
Paula Gould, University of Leeds press office: Tel 0113 343 8059, email [email protected]

Notes for editors:

  1. First-line treatment with zoledronic acid as compared with clodronic acid in multiple myeloma (MRC Myeloma IX): a randomised controlled trial. Gareth J Morgan, Faith E Davies, Walter M Gregory, Kim Cocks, Sue E Bell, Alex J Szubert, Nuria Navarro-Coy, Mark T Drayson, Roger G Owen, Sylvia Feyler, A John Ashcroft, Fiona Ross, Jennifer Byrne, Huw Roddie, Claudius Rudin, Gordon Cook, Graham H Jackson, J Anthony Child, on behalf of the NCRI Haematological Oncology Clinical Study Group. Lancet 2010; 376: 1989-99.
  2. The trial was conceived and designed by Professor Gareth J Morgan, Professor J Anthony Child and CTRU. Researchers at CTRU also handled most of the day-to-day coordination and data management, and analysis of the results. The trial was sponsored by the University of Leeds. Leeds Teaching Hospitals NHS Trust was the lead clinical centre for the study.
  3. One of the UK’s largest medical, health and bioscience research bases, the University of Leeds delivers world leading research in medical engineering, cancer, cardiovascular studies, epidemiology, molecular genetics, musculoskeletal medicine, dentistry, psychology and applied health. Treatments and initiatives developed in Leeds are transforming the lives of people worldwide with conditions such as diabetes, HIV, tuberculosis and malaria.
  4. For almost 100 years the Medical Research Council has improved the health of people in the UK and around the world by supporting the highest quality science. The MRC invests in world-class scientists. It has produced 29 Nobel Prize winners and sustains a flourishing environment for internationally recognised research. The MRC focuses on making an impact and provides the financial muscle and scientific expertise behind medical breakthroughs, including the first antibiotic penicillin, the structure of DNA and the lethal link between smoking and cancer. Today MRC funded scientists tackle research into the major health challenges of the 21st century.
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