Research project
Immunotherapy approaches adapted for fitness in newly diagnosed transplant ineligible patients with myeloma (iFIT)
- Start date: 3 July 2026
- End date: 1 January 2037
- Funder: Cancer Research UK, Blood Cancer UK, and Johnson & Johnson Innovative Medicine
- Primary investigator: Professor Gordon Cook
- Co-investigators: Professor David Cairns, Dr Christopher Parrish, Professor David Meads, Dr Kara-Louise Royle
- External co-investigators: Co-Chief Investigator: Dr Charlotte Pawlyn. Other co-investigators: Dr John Jones, Dr Ruth de Tute, Dr Sally Moore, Dr Sandra Quinn
Description
iFIT is a trial for patients newly diagnosed with the bone marrow cancer myeloma. These patients are generally older and have a lower level of fitness than others. Patients can take part if their doctor would otherwise recommend the standard NHS treatment daratumumab, lenalidomide and dexamethasone (DRd).
The treatment a patient receives in iFIT is based on two factors. These are:
- How fit the patient is, and
- How well their myeloma responds to 6 months of DRd treatment.
Fitness is measured using a well-tested process dividing patients into groups: FIT, UNFIT, and FRAIL. Response to treatment will be assessed using a sensitive test of a bone marrow sample looking for detectable myeloma.
For FIT/UNFIT patients who have detectable myeloma after 6 months of DRd treatment, we will test whether some new immunotherapy treatments can improve outcomes compared to continuing on DRd (considered the standard approach). Immunotherapy treatments help patients’ immune system fight diseases. The new treatments are called teclistamab and talquetamab. They are given with daratumumab.
For FRAIL patients who have detectable myeloma after 6 months of DRd treatment, we will test whether stopping dexamethasone helps patients to continue on the remaining treatments for longer with fewer side effects.
For patients who do not have detectable myeloma after 6 months of DRd treatment, we will test whether they need to continue treatment long-term (considered the standard approach) or can stop after a total of 2 years.
Patients will be invited to participate by their hospital doctor. Taking part will give patients the chance to access new therapies earlier. Patients will be asked to provide more bone marrow and blood tests and may need to attend hospital more often.
The trial will help us understand how to improve treatment for newly diagnosed patients with myeloma.
More information can be found on the project webages; on the IRCTN webpage, the UK’s clinical study registry; or on Clinicaltrials.gov.
Impact
When the research is complete, the results will be published in a medical journal and on UK cancer organisation websites such as Myeloma UK, Cancer Research UK, and Blood Cancer UK.
Results of research projects are often presented at large medical meetings to make sure as many doctors as possible know about the results. This is how research can improve treatment and care.
Research like this can take a while to complete. The results might not be ready for a number of years.