A Phase 3 interventional study of Daratumumab and Lenalidomide in Multiple Myeloma (MM) and Plasma Cell Leukemia (PCL), sponsored by University of Leeds. Recruiting at 5 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by University of Leeds · Phase 3, Interventional, and Treatment
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.
60 studies on the registry are indexed under Leukemia, Plasma Cell; 33 are open to participants now.
This study's planned enrollment of 1,226 is above the median of 27 across 53 interventional studies indexed under Leukemia, Plasma Cell.
Browse Leukemia, Plasma Cell studies →University of Leeds is the lead sponsor of 206 studies on the registry; 25 are open to participants now.
Compared within Leukemia, Plasma Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Multiple Myeloma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligibility criteria for registration:
Inclusion criteria for registration:
Exclusion criteria for registration:
Additional eligibility criteria for randomisation into iFIT1/iFIT2/iFIT3 pathways, as follows:
Inclusion criteria for randomisation into all iFIT1/iFIT2/iFIT3 pathways:
Inclusion criteria specific to randomisation pathways:
Exclusion criteria for randomisation into all iFIT1/iFIT2/iFIT3 pathways:
Exclusion criteria specific to randomisation pathways:
Full inclusion and exclusion criteria are listed in the protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive standard of care treatment with daratumumab, lenalidomide, and dexamethasone for an initial 6 cycles.
Drug: Daratumumab · Drug: Lenalidomide · Drug: Dexamethasone
Participants 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.
Drug: Daratumumab · Drug: Lenalidomide · Drug: Dexamethasone
Participants 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.
Drug: Daratumumab · Drug: Teclistamab
Participants 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.
Drug: Daratumumab · Drug: Talquetamab
Participants assigned to the iFIT2 pathway and randomised to this arm will continue standard of care treatment with daratumumab, lenalidomide, and dexamethasone until progressive disease.
Drug: Daratumumab · Drug: Lenalidomide · Drug: Dexamethasone
Participants assigned to the iFIT2 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.
Drug: Daratumumab · Drug: Lenalidomide
Participants assigned to the iFIT3 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.
Drug: Daratumumab · Drug: Lenalidomide
Participants 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.
Drug: Daratumumab · Drug: Lenalidomide
Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
Also known as: D, Dara
Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Also known as: R, Revlimid
Taken as oral tablets, oral solution, or given by IV. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Also known as: d
Participants will receive teclistamab by subcutaneous injection. Each cycle is 28 days.
Also known as: Tec
Participants will receive talquetamab by subcutaneous injection. Each cycle is 28 days.
Also known as: Tal
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Progression-free survival (PFS; iFIT2 only)
The time from iFIT2 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.
Time frame: From iFIT2 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
Time to progression (TTP)
The time from iFIT1/iFIT2/iFIT3 randomisation to first documented evidence of disease progression. Participants who died without progression will be censored at their date of death. Participants alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free.
Time frame: 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)
The time from iFIT1/iFIT2/iFIT3 randomisation to the second documented evidence of progressive disease or death from any cause. Participants alive and for whom a second progression has not been observed at the time of analysis will be censored at their last known date to be alive and second progression-free.
Time frame: From iFIT1/iFIT2/iFIT3 randomisation to PFS2 event, assessed up to a maximum of 10.5 years post-randomisation.
Overall survival (OS)
The time from iFIT1/iFIT2/iFIT3 randomisation to death from any cause. Participants alive at the time of analysis will be censored at their last known date to be alive.
Time frame: 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)
The time from iFIT1 randomisation to the first of the following events: grade 4 haematological AEs (anaemia, neutropenia, thrombocytopenia), 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.
Time frame: From iFIT1 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
Survival after progression
The time from first documented evidence of disease progression to death from any cause. Participants alive at the time of analysis will be censored at their last known date to be alive. This endpoint is only defined for those who experience progression.
Time frame: From disease progression to death, assessed up to a maximum of 10.5 years post-randomisation.
Time to next treatment (TTNT)
The time from registration to the date of commencement of next treatment. Participants who do not receive next line treatment will be censored at the date of the last assessment or follow-up visit where they are known to have received no new therapy.
Time frame: From registration to TTNT event, assessed up to a maximum of 10.5 years post-randomisation.
Overall response rate (ORR)
Overall response rate using the disease response category (sCR, CR, VGPR, PR, MR, SD, or PD).
Time frame: Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
Attainment of ≥VGPR
Attainment of ≥VGPR using the binary disease response category (≥VGPR: sCR, CR, VGPR vs. \<VGPR: PR, MR, SD, PD).
Time frame: Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
Attainment of MRD negativity
Attainment of MRD negativity using the binary MRD status category (negative vs. positive) measured using flow cytometry. MRD negativity is defined as at least a serological VGPR and MRD negative bone marrow aspirate at the 10\^-5 threshold.
Time frame: Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
Maximum response
The maximum response attained.
Time frame: From iFIT1/iFIT2/iFIT3 randomisation up to a maximum of 6.5 years post-randomisation.
Time to improved response
The time from iFIT1/iFIT2/iFIT3 randomisation to first recorded improved response, where the baseline response is that recorded at the start of randomised treatment (iFIT1/iFIT2/iFIT3 cycle 1, day 1). Participants whose disease progresses or who die before an improved response is recorded will be censored at the time of progression or death, respectively. Participants alive with no improved response recorded at the time of analysis will be censored at their last known date to be alive.
Time frame: From iFIT1/iFIT2/iFIT3 randomisation to first recorded improved response, up to a maximum of 6.5 years post-randomisation.
Treatment compliance
Treatment compliance including whether all cycles of treatment were completed, the number of cycles completed, the total dose of each trial medication received, the number and causes of dose omissions, dose delays, and dose reductions.
Time frame: From registration to the end of trial treatment, up to a maximum of 7 years post-registration.
Toxicity and safety as graded by NCI-CTCAE v5
Toxicity and safety based on the adverse events reported as graded by NCI-CTCAE v5. Pregnancies will also be reported.
Time frame: From registration up to a maximum of 11 years post-registration. SAEs may be reported up to 60 days post-last dose of protocol treatment/cycle of active monitoring.
Incidence of secondary primary malignancies
The number and details of all other cancers, defined as secondary primary malignancies.
Time frame: Measured during standard of care induction DRd treatment and following iFIT1/ iFIT2/iFIT3 randomisation, up to a maximum of 11 years post-registration.
Incidence, rate, and type of infections as graded by NCI-CTCAE v5
Measured using the proportion of participants experiencing an infection of any type or grade as graded by NCI-CTCAE v5.
Time frame: Measured during standard of care induction DRd treatment and following iFIT1/iFIT2/iFIT3 randomisation, up to a maximum of 7 years post-registration.
Quality of life using questionnaires
Measured using the EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-IL413 questionnaires. This will also be measured using the EORTC QLQ IL414 questionnaire and the Scale of Subjective Total Taste Acuity (STTA) at specified timepoints only.
Time frame: Measured at the start of cycle 1 and after 6 28-day cycles of DRd induction, and timepoints up to 30 months post-randomisation. The IL414 is measured at the induction timepoints and in iFIT1, and the STTA after 6 28-day cycles of induction and in iFIT1.
Objective measures of function
Measured using the 4 metre walk test and mini-cog assessments.
Time frame: Measured at the start of cycle 1, after 3 28-day cycles, and after 6 28-day cycles of standard of care induction DRd.
Cost-utility
Measured using costs, QALYs and net health benefit (QALYs below £20,000).
Time frame: Measured at the start of cycle 1 of DRd induction, after 6 28-day cycles of DRd induction, and further timepoints up to 30 months post-iFIT1/iFIT2/iFIT3 randomisation.
Exploratory endpoint - investigation into bone disease and therapy
Observe and understand current UK bone therapy practice and investigate how it impacts on various bone and clinical myeloma outcomes, in order to generate hypotheses to inform future research in this area. This includes bone therapy planned and prescribed, dental assessment received, and bone disease (including SREs) experienced.
Time frame: From registration up to a maximum of 7 years post-registration.
Exploratory endpoint - infection interactions and infection risk (iFIT1 only)
Certain genetic characteristics and medical history are suspected to influence the incidence and rate of infections. These will be investigated under this endpoint including iVIG usage and vaccination history. The ability to predict prospectively which participants are most at risk of infections could support the implementation of novel immunotherapies in practice. This will also be investigated under this endpoint.
Time frame: From iFIT1 randomisation up to a maximum of 6.5 years post-randomisation.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Start is estimated for Jul 2026; primary completion for Jun 2033, 83 months later.
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Studies of the drugs tested here: Lenalidomide · Teclistamab · Talquetamab