The purpose of the Myeloma XII trial is to see if using a novel drug called ixazomib (Ninlaro®) can strengthen the effect of a second high-dose therapy and stem cell transplant (HDT-SCT).
Myeloma UK is looking to speak to patients with relapsing myeloma who have received a new combination treatment to help provide evidence in favour of the approval of the treatment in Scotland.
The National Institute for Health and Care Excellence (NICE), the drug approval body for England and Wales, has published draft negative guidance for daratumumab (Darzalex®) monotherapy (for use on its own and not in combination with other drugs). This means that, as it stands, it is unlikely to be made available in this setting on the NHS for relapsed and refractory myeloma. Myeloma UK Policy and Public Affairs Manager, Kate Morgan said, “This is a very disappointing decision for myeloma patients in England and Wales, but it was always going to be a challenging appraisal.”
Myeloma UK has launched clinical trial MUK eleven which will open to recruitment imminently. It is a first of its kind immunotherapy trial which aims to encourage the immune system to target myeloma cells.
The European licence for daratumumab (Darzalex) is to be extended to be used in combination with other myeloma drugs for the treatment of relapsed patients who have had at least one prior therapy. Currently daratumumab is licensed for use in Europe on its own, which is known as a monotherapy.
Myeloma UK has called for patients, family members and carers to be more involved in developing guidance published by the National Institute for Health and Care Excellence (NICE). NICE, the drug approval body for England and Wales, had asked for views on proposals to improve how patients and the public can contribute to developing guidance on new treatments and care standards. A response submitted by Myeloma UK acknowledged the work NICE does to involve patients and the public but highlighted important areas where there is more to be done.
As a representative of the Scottish Cancer Coalition, Myeloma UK is participating in the Cancer Medicines Outcome Programme (CMOP) in Scotland with Dr Jayne Galinksy, Myeloma UK Health Services Research Manager, joining its Programme Board. CMOP is a 3 year Scottish Government funded programme, led by NHS Greater Glasgow and Clyde in collaboration with the University of Strathclyde, designed to determine the clinical effectiveness of cancer medicines in a real-life setting.
Myeloma UK has joined forced with Edinburgh-based charity VOCAL (Voice of Carers Across Lothian) to offer family members and friends of myeloma patients a new free training session called, “Caring with someone with myeloma.”
Findings have been published from the MUK six clinical trial, a trial conducted as part of the Myeloma UK Clinical Trial Network. Myeloma UK Research Director, Simon Ridley, explains how the findings could help myeloma patients in the future.
Revlimid is already licensed by the EMA in all stages of relapse and as a treatment for newly diagnosed patients who are ineligible for transplant. If approved this further recommendation will extend the existing licence. The European Commission now has 60 days to issue final guidance.