RecruitingPhase 3

Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level

United Kingdom1,226 participantsStarted 2026-07

Plain-language summary

iFIT is a trial for newly diagnosed transplant-ineligible patients 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). After six months of DRd, the subsequent treatment a patient receives in iFIT is based on two factors: the patient's fitness level and treatment response. The trial compares different treatment strategies to determine whether outcomes can be improved for specific patient groups.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Newly diagnosed as having symptomatic MM, plasma cell leukaemia or non-secretory MM according to IMWG diagnostic criteria 2014.
. Considered not suitable to receive autologous stem cell transplant as part of their first line therapy by the treating clinician,
. Planned for treatment with Daratumumab, Lenalidomide and dexamethasone (DRd) as first line therapy as standard of care,
. Aged 18 years or greater,
. Able to provide full informed consent, and
. Prepared to comply with pregnancy prevention plan.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is still listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to start standard NHS treatment now rather than waiting to see if I qualify?
2The trial seems to tailor treatment based on how well I respond early on and how fit I am overall — can you explain how my current fitness level and initial response to treatment might affect which part of this trial I'd potentially be placed in?
3Since this is a Phase 3 trial for multiple myeloma and plasma cell leukemia, what do we already know about the treatments being tested here compared to what I'd receive through standard NHS care right now?
4One of the main things this trial is measuring is progression-free survival alongside quality of life — given my specific situation, how do you think those two goals would be balanced if I were to discuss enrolment once the trial opens?
5Because the trial covers both multiple myeloma and plasma cell leukemia, which are quite different in how aggressive they can be, how does my specific diagnosis affect whether this trial might even be worth exploring as an option for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

iFIT1: Progression-free survival (PFS)

Timeframe: From iFIT1 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.

iFIT2: Event-free survival (EFS)

Timeframe: From iFIT2 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.

iFIT3: Progression-free survival (PFS) and participant-reported overall health and quality of life (QoL) - co-primary outcomes

Timeframe: PFS: from iFIT3 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation. QoL: measured at the start of cycle 1 and after 6 28-day cycles of DRd induction, and further timepoints up to 30 months post-iFIT3 randomisation.

Trial details

NCT IDNCT07649525

SponsorUniversity of Leeds

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2033-06

Contact for this trial

Emma McNaught

0113 343 1978 ctru-ifit@leeds.ac.uk

View on ClinicalTrials.gov More Multiple Myeloma (MM) trials