MUK one clinical trial re-opens

The first clinical study in the Myeloma UK Early Phase Clinical Trial Network, known as MUK one, has re-opened after a temporary pause in September 2011. The study aims to identify a suitable dose for bendamustine (a type of chemotherapy) when given in combination with thalidomide and dexamethasone, in relapsed and/or refractory myeloma patients.

During a routine review of the study data at the end of September 2011, it was paused whilst the data monitoring and ethics committee (DMEC) assessed the safety and side-effect profile of the two dosing groups, 60 or 100 mg/m2 of bendamustine. This is not uncommon during clinical studies, where patient safety is of utmost importance. After careful review, it was decided that the 60 mg/m2 would re-open, but no more patients would be recruited into the high-dose group.

This change to the study protocol has now been approved by the Medicines and Healthcare Regulatory Agency (MHRA) and the Medicines Research Ethics Committee (MREC). This study has now been re-opened to recruitment, and the first hospital open to MUK one is St James's Hospital in Leeds.

All eight hospitals in the Clinical Trial Network are participating in MUK one, recruiting patients from London, Birmingham, Nottingham, Leeds and Manchester. The study is co-ordinated from a central Clinical Trials Office in Leeds.

If you are interested in participating in the study talk to your doctor. For more information on the Clinical Trial Network email heather@myeloma.org.uk