Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level
iFIT
iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma
1 other identifier
interventional
1,226
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2026
Longer than P75 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2026
CompletedFirst Posted
Study publicly available on registry
June 16, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2037
July 15, 2026
July 1, 2026
6.9 years
June 2, 2026
July 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
iFIT1: Progression-free survival (PFS)
The time from iFIT1 randomisation to progression or death from any cause. Participants alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free.
From iFIT1 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
iFIT2: Event-free survival (EFS)
The time from iFIT2 randomisation to the first of the following events: grade 4 haematological AEs, grade 3 and 4 non-haematological AEs (including SPMs), discontinuation of trial treatment, progression or death. Participants event-free at the time of analysis will be censored at their last date known to be alive and event-free.
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
PFS: The time from iFIT3 randomisation to progression or death from any cause. Participants alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free. QoL: The GHS/QoL scale score of the EORTC QLQ-C30 questionnaire. The QoL primary endpoint is measured at 30 months (2.5 years) after iFIT3 randomisation.
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.
Secondary Outcomes (19)
Progression-free survival (PFS; iFIT2 only)
From iFIT2 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
Time to progression (TTP)
From iFIT1/iFIT2/iFIT3 randomisation to TTP event, assessed up to a maximum of 10.5 years post-randomisation.
Time to second PFS event (PFS2)
From iFIT1/iFIT2/iFIT3 randomisation to PFS2 event, assessed up to a maximum of 10.5 years post-randomisation.
Overall survival (OS)
From iFIT1/iFIT2/iFIT3 randomisation to OS event, assessed up to a maximum of 10.5 years post-randomisation.
Event-free survival (EFS; iFIT1 only)
From iFIT1 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
- +14 more secondary outcomes
Other Outcomes (2)
Exploratory endpoint - investigation into bone disease and therapy
From registration up to a maximum of 7 years post-registration.
Exploratory endpoint - infection interactions and infection risk (iFIT1 only)
From iFIT1 randomisation up to a maximum of 6.5 years post-randomisation.
Study Arms (8)
DRd induction
ACTIVE COMPARATORAll participants will receive standard of care treatment with daratumumab, lenalidomide, and dexamethasone for an initial 6 cycles.
iFIT1 - DRd to PD
ACTIVE COMPARATORParticipants assigned to the iFIT1 pathway and randomised to this arm will continue standard of care treatment with daratumumab, lenalidomide, and dexamethasone until progressive disease. Dexamethasone may be stopped due to toxicity.
iFIT1 - Daratumumab plus teclistamab (Dara-Tec)
EXPERIMENTALParticipants assigned to the iFIT1 pathway and randomised to this arm will receive treatment with daratumumab and teclistamab for a fixed duration and then be actively monitored until progressive disease.
iFIT1 - Daratumumab plus talquetamab (Dara-Tal)
EXPERIMENTALParticipants assigned to the iFIT1 pathway and randomised to this arm will receive treatment with daratumumab and talquetamab for a fixed duration and then be actively monitored until progressive disease.
iFIT2 - DRd to PD
ACTIVE COMPARATORParticipants assigned to the iFIT2 pathway and randomised to this arm will continue standard of care treatment with daratumumab, lenalidomide, and dexamethasone until progressive disease.
iFIT2 - DR to PD
EXPERIMENTALParticipants assigned to the iFIT2 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.
iFIT3 - DR to PD
ACTIVE COMPARATORParticipants assigned to the iFIT3 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.
iFIT3 - DR for 18 cycles
EXPERIMENTALParticipants assigned to the iFIT3 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide for 18 cycles, and then be actively monitored until progressive disease.
Interventions
Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Taken as oral tablets, oral solution, or given by IV. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Participants will receive teclistamab by subcutaneous injection. Each cycle is 28 days.
Participants will receive talquetamab by subcutaneous injection. Each cycle is 28 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Smouldering myeloma (SMM), primary amyloidosis, solitary plasmacytoma of bone or extramedullary plasmacytoma (without additional evidence of myeloma),
- 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,
- Previous treatment for myeloma, except as specified in the protocol,
- Active systemic viral, fungal or bacterial infection requiring systemic therapy. Criteria for specific chronic infections clarified in the protocol, or
- 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:
- 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.
- 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),
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leedslead
- Cancer Research UKcollaborator
- Blood Cancer UKcollaborator
- Johnson & Johnsoncollaborator
Study Sites (5)
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Eastbourne District General Hospital
Eastbourne, BN21 2UD, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
The Clatterbridge Cancer Centre - Liverpool
Liverpool, L7 8YA, United Kingdom
The Royal Marsden Hospital
London, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gordon Cook
Leeds Institute of Clinical Trials Research
- STUDY CHAIR
Charlotte Pawlyn
Institute of Cancer Research, United Kingdom
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2026
First Posted
June 16, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
June 1, 2033
Study Completion (Estimated)
June 1, 2037
Last Updated
July 15, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available at the end of the trial, i.e. usually when all primary and secondary endpoints have been met and all key analyses are complete. Data will remain available from then on for as long as CTRU retains the data.
- Access Criteria
- Data will be released for legitimate secondary research purposes, where the Chief Investigators, Sponsor and CTRU agree that the proposed use has scientific value and will be carried out to a high standard (scientific rigour and information governance and security), and that suitable resources are available. Data will be released in line with participants' consent, all applicable laws relating to data protection and confidentiality, and any contractual obligations to which the CTRU is subject. No IPD will be released before an appropriate agreement is in place governing data retention, usually stipulating that data recipients must delete their copy of the data at the end of the project. The CTRU believes it is best practice for researchers who generated datasets to be involved in subsequent uses of those datasets. Recipients of trial data for secondary research will also receive data dictionaries, key trial documents and any other information required to reuse the datasets.
De-identified individual participant data datasets generated and/or analysed during the current study will be available upon request from the Clinical Trials Research Unit, University of Leeds (contact CTRU-DataAccess@leeds.ac.uk in the first instance). The conditions of release for aggregate data may differ from those applying to individual participant data. Requests for aggregate data should also be sent to the above email address to discuss and agree suitable requirements for release.