Question to the Department of Health and Social Care:

To ask Her Majesty’s Government which of the four phase 2 or 3 clinical trials for systemic amyloidosis approved since 2004 are still ongoing; and whether any of the trials have produced sufficient positive outcomes to encourage commercial development.

There are four trials for systemic amyloidosis that are designated as ‘ongoing’ in the United Kingdom. These are being conducted by two commercial sponsors, Millennium Pharmaceuticals Inc and A.T. Development Switzerland Sarl (two studies), and one non-commercial sponsor, European Myeloma Network.

Clinical trial sponsors are required to publish a summary of their trial results to the EU Clinical Trials Register within one year of their trial completing. At that point, these results will become publically available on the EU Clinical Trials Register

The Department of Health, which funds the National Institute for Health Research (NIHR), is a member of the National Cancer Research Institute (NCRI). NCRI Clinical Studies Groups (CSGs) bring together clinicians, scientists, statisticians and lay representatives to coordinate development of a strategic portfolio of trials within their field. All CSGs interact with clinical research networks, funders (including NIHR) and researchers to develop studies aimed at improving outcomes for patients. The Haematological Oncology CSG has a Myeloma Subgroup and its 2013-14 annual report that includes an assessment of progress in these areas is attached and available on the NCRI website at:

http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf.

We cannot comment on commercial considerations. When the results are known, the commercial potential of these trial’s products will be a matter for the respective trial sponsors.