In preparation for the trial Myeloma UK worked closely with Takeda initiating a first-of-its kind pilot, by going jointly to NICE to seek scientific advice on both TOURMALINE-MM1 and MUK eight

This is the first time a medical research charity and a pharmaceutical company have gone jointly to NICE Scientific Advice. Myeloma UK announces that MUK eight, a Phase II trial of the oral proteasome inhibitor, ixazomib, is now open for recruitment.

MUK eight is a randomised Phase II trial comparing the novel oral proteasome inhibitor ixazomib in combination with cyclophosphamide and dexamethasone, against a combination of cyclophosphamide and dexamethasone in relapsed and/or refractory myeloma patients.

This is the eighth trial to be set up within the Myeloma UK Clinical Trial Network (CTN) and will recruit 250 patients from 20 of the 35 Myeloma UK CTN centres across the UK.

MUK eight was designed by the CTN and part-funded by Takeda Oncology. It will complement the regulatory trial TOURMALINE-MM1, conducted by Takeda, with the aim of providing additional and complementary evidence to support the Health Technology Assessment (HTA) and NHS Commissioning of ixazomib in the UK.

In preparation for the trial Myeloma UK worked closely with Takeda, initiating a first-of-its kind collaboration and pilot by going jointly to NICE to seek scientific advice on both TOURMALINE-MM1 and MUK eight.

The trial forms part of the Myeloma UK strategy to work in partnership with industry, and the English HTA and payer body to improve evidence generation for HTA evaluation. The overall aim is to reduce uncertainty, maximise chances for a quicker approval in the UK, and support the seamless adoption and diffusion of new treatments into the NHS.

Myeloma UK Chief Executive Eric Low explains, “For far too long there has been a lack of strategic cohesion between the policies that have been put in place at different stages of the drug development cycle, and an absence of forethought or understanding as to how one stage of the process impacts on another. As a consequence issues around how new myeloma treatments are appraised, approved for use and commissioned in the UK has resulted in an unacceptable situation whereby patients do not get access to the treatments that they need when they need them.

“The Myeloma UK Clinical Trial Network aims to address these issues. Since its launch, the Clinical Trial Network has championed a more strategic approach to clinical development programmes balancing out international commercial and regulatory data requirements with those in the UK, and prioritising the most promising myeloma drugs in the pipeline, based on the needs of patients.”

Dr Leeza Osipenko who heads NICE Scientific Advice said, “This was one of the most interesting advice projects we’ve conducted over the years as for the first time we were presented with the plans for the global clinical development programme along with a national trial. We hope this pilot leads to future three-way engagements for early dialogues with the industry and patient organisations.”

Takeda UK Director of Market Access Ross Selby adds, “We are thankful to Myeloma UK, the investigators and NICE for being open to working together to help increase access for UK patients to innovative drugs such as ixazomib, the first oral proteasome inhibitor.”

The Myeloma UK CTN takes a prioritised and strategic approach to clinical trials and is predicated on accelerated set up, rapid recruitment and the seamless adoption and diffusion of research results into clinical practice.

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