iFIT Trial 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). This is an approved treatment for people newly diagnosed with myeloma who are not suitable for a stem cell transplant.
Who can participate?
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.
What does the study involve?
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.
The trial will help us understand how to improve treatment for newly diagnosed patients with myeloma.