iFIT (UK-MRA Myeloma XVIII)
Research type
Research Study
Full title
Immunotherapy approaches adapted for Fitness In newly diagnosed Transplant ineligible patients with Myeloma
IRAS ID
1010810
Contact name
Emma Armstrong
Contact email
Sponsor organisation
University of Leeds
Research summary
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 1) how fit the patient is and 2) 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). The new treatments are called teclistamab and talquetamab. They are given with daratumumab. Immunotherapy treatments help patients' immune system fight diseases.
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.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0279
Date of REC Opinion
25 Sep 2025
REC opinion
Further Information Favourable Opinion