NCT07649525 Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level
| NCT ID | NCT07649525 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Leeds |
| Condition | Multiple Myeloma (MM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,226 participants |
| Start Date | 2026-07 |
| Primary Completion | 2033-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,226 participants in total. It began in 2026-07 with a primary completion date of 2033-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Eligibility criteria for registration: Inclusion criteria for registration: 1. Newly diagnosed as having symptomatic MM, plasma cell leukaemia or non-secretory MM according to IMWG diagnostic criteria 2014. 2. Considered not suitable to receive autologous stem cell transplant as part of their first line therapy by the treating clinician, 3. Planned for treatment with Daratumumab, Lenalidomide and dexamethasone (DRd) as first line therapy as standard of care, 4. Aged 18 years or greater, 5. Able to provide full informed consent, and 6. Prepared to comply with pregnancy prevention plan. Exclusion criteria for registration: 1. Smouldering myeloma (SMM), primary amyloidosis, solitary plasmacytoma of bone or extramedullary plasmacytoma (without additional evidence of myeloma), 2. Pregnant, breastfeeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within 3 months after the last dose, 3. Previous treatment for myeloma, except as specified in the protocol, 4. Active systemic viral, fungal or bacterial infection requiring systemic therapy. Criteria for specific chronic infections clarified in the protocol, or 5. Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring. Additional eligibility criteria for randomisation into iFIT1/iFIT2/iFIT3 pathways, as follows: Inclusion criteria for randomisation into all iFIT1/iFIT2/iFIT3 pathways: * Completed 6 cycles of DRd induction therapy after registering within the iFIT study, * Able to provide full informed consent, and * Prepared to comply with pregnancy prevention plan. Inclusion criteria specific to randomisation pathways: * Dexamethasone may have been stopped due to toxicity and the participant will remain eligible (iFIT1 and iFIT3), * Planned to continue on at least daratumumab (monthly) and lenalidomide (at any dose level) (iFIT1 and iFIT3), * Planned to continue on all three DRd medications (dose reductions are allowed) (iFIT2), * Achieved a partial response (PR) biochemically (irrespective of MRD status) or achieved a ≥VGPR and are MRD positive, as confirmed by HMDS (central laboratory) (iFIT1 and iFIT2), * Achieved a ≥VGPR and are MRD negative, as confirmed by HMDS (central laboratory) (iFIT3), * Categorised as FIT or UNFIT according to the IMWG frailty index (iFIT1), * Categorised as FRAIL according to the IMWG frailty index (iFIT2), and * Meet the blood criteria specified in the protocol within 14 days before randomisation (haematological and biochemical) (iFIT1). Exclusion criteria for randomisation into all iFIT1/iFIT2/iFIT3 pathways: * Received systemic anti-myeloma therapy other than DRd prior to randomisation. Steroids given (by any route) for reasons other than myeloma disease control are allowed, * Received a stem cell transplant, * Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring, and * Pregnant, breast feeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within a specified period after the last dose. Exclusion criteria specific to randomisation pathways: * Stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT1 and iFIT2), * Partial response (PR), stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT3), and * Further exclusion criteria related to safety of interventions (iFIT1). Full inclusion and exclusion criteria are listed in the protocol.
Contact & Investigator
Gordon Cook
STUDY CHAIR
Leeds Institute of Clinical Trials Research
Frequently Asked Questions
Who can join the NCT07649525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma (MM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07649525 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,226 participants.
Is NCT07649525 currently recruiting?
Yes, NCT07649525 is actively recruiting participants. Contact the research team at ctru-ifit@leeds.ac.uk for enrollment information.
Where is the NCT07649525 trial being conducted?
This trial is being conducted at Bristol, United Kingdom, Eastbourne, United Kingdom, Leeds, United Kingdom, Liverpool, United Kingdom and 1 additional location.
Who is sponsoring the NCT07649525 clinical trial?
NCT07649525 is sponsored by University of Leeds. The principal investigator is Gordon Cook at Leeds Institute of Clinical Trials Research. The trial plans to enroll 1,226 participants.