Case Study - Myeloma IX Myelomatosis therapy trial for patients of all age groups.
This phase III study showed that zoledronic acid, in addition to reducing skeletal damage, showed an overall survival benefit and introduced the use of thalidomide as an effective yet less toxic therapy.
Prof JA Child, Prof GJ Morgan, Prof FE Davies and Prof GH Jackson
Medical Research Council, Celgene, Novartis, Orthobiotec
MRC Myeloma IX built on the results of Myeloma VII, but with the addition of novel oral agent thalidomide to overcome toxicity associated with infusional chemotherapy. The trial showed thalidomide to be an effective therapy for myeloma associated with fewer toxic effects and has since become a standard treatment for myeloma.
Myeloma IX also included a new bisphosphonate, zoledronic acid, to assess the control of bone damage, as compared to standard bisphosphonates. Myeloma IX showed that zoledronic acid significantly reduced bone damage in comparison with the standard bisphosphonate, clodronate, but also is associated with a survival benefit of 8 months. This too is now considered a standard treatment for myeloma. The use of zoledronic acid has been incorporated into professional guidelines in the USA, Canada and Europe.
Myeloma IX included older, less-fit patients in a non-intensive treatment pathway – a large group clinically, but one previously excluded from trials. Treatment incorporating thalidomide provided a survival benefit for those patients surviving more than 2 years.