New UK-wide clinical trial for transplant-ineligible myeloma patients opens to recruitment

Other News // 16th December 2020

Leeds University Clinical Trials Unit have confirmed the launch of a new phase III clinical trial (Myeloma XIV: FiTNEss trial) for newly diagnosed myeloma patients who are not eligible for high-dose therapy and stem cell transplantation (HDT-SCT).

HDT-SCT improves the average remission time and life expectancy of myeloma patients but frailty and fitness levels mean many are considered ineligible for HDT-SCT. Consequently, treatment often has to be altered or discontinued early for older, less fit myeloma patients due to side effects, problems with tolerability, or through patient choice. This means older, less fit patients often have poorer outcomes than younger, fitter patients creating a clear, unmet need for better, kinder treatments for older, less fit patients.

The trial which is funded by Cancer Research UK and Millennium Pharmaceuticals (Takeda) will involve 740 patients from approximately 90 hospitals across the UK.

It aims to improve the outcomes of HDT-SCT ineligible patients by assessing whether adapting treatment based on a patients’ frailty can keep them on medication for longer.

It will use the International Myeloma Working Group frailty scoring system to evaluate age, other illnesses, and whether a patient can live independently, before categorising patients as fit, unfit, or frail. These different groups can then be given different medication strengths.

Gordon Cook, Professor of Haematology and Myeloma Studies and Clinical Director (Haematology) at Leeds Institute of Clinical Trials Research, said:

“This is the only trial globally looking to test if a clinical score can identify vulnerable patients at risk of treatment-related toxicity and modifying how we deliver therapy up-front rather than in response to developing side effects, which is the standard of care.

The international myeloma community is eager to see the outcomes from this trial, which has the potential to change how we practise delivering care in our clinics.”

Sarah McDonald, Myeloma UK Director of Research and Patient Advocacy, said:

“This is another great breakthrough in myeloma trials. Importantly, the trial targets older and less fit patients who are often excluded from trials, giving them a chance to access new treatments. It also aims to identify the patients who are more likely to stop treatment early due to side effects, and adjust their treatment in advance. This is a huge step towards personalised medicine in myeloma.

But the trial design is also good news for myeloma patients, especially during the COVID-19 pandemic, as it gives them the opportunity to have a triplet of tablets at first line. This means that patients joining this trial will get more home and community-based treatment and it alters the frequency of visits to a hospital for treatment, reducing risk from infection.”