Multiple Myeloma (MM)Phase 3iFITNCT07649525
Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level
A Phase 3 study testing Daratumumab, Lenalidomide and Dexamethasone in people with Multiple Myeloma (MM) and Plasma Cell Leukemia (PCL), run by University of Leeds at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM), Plasma Cell Leukemia (PCL)
- What is being tested?
- Daratumumab, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,226 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Jul 2026to Jun 2037
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Catherine Olivier contact
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
Sally Moore, Dr, ctru-ifit@leeds.ac.uk
- Not yet recruiting
Eastbourne District General Hospital
Eastbourne, BN21 2UD
John Jones, Dr, ctru-ifit@leeds.ac.uk
- Not yet recruiting
St James University Hospital
Leeds, LS9 7TF
Frances Seymour, Dr, ctru-ifit@leeds.ac.uk
- Recruiting
The Clatterbridge Cancer Centre - Liverpool
Liverpool, L7 8YA
Dr Stephen Hawkins
- Not yet recruiting
The Royal Marsden Hospital
London, SM2 5PT
Katy Smith, Dr, ctru-ifit@leeds.ac.uk
About this study
Official title: iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma
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.
- Conditions
- Multiple Myeloma (MM), Plasma Cell Leukemia (PCL)
- Being tested
- Daratumumab, Lenalidomide, Dexamethasone, Teclistamab, Talquetamab
- Keywords
- Myeloma, Platform adaptive design, Immunotherapy, Frailty, Personalised therapy, Biomarker-driven
- Medical subject headings
- Multiple Myeloma, Leukemia, Plasma Cell, Neoplasms, Plasma Cell, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Also called D, Dara
Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
LenalidomideDrug
Also called R, Revlimid
Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
DexamethasoneDrug
Also called d
Taken as oral tablets, oral solution, or given by IV. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
TeclistamabDrug
Also called Tec
Participants will receive teclistamab by subcutaneous injection. Each cycle is 28 days.
TalquetamabDrug
Also called Tal
Participants will receive talquetamab by subcutaneous injection. Each cycle is 28 days.
| Study group | Role | What they receive |
|---|---|---|
| DRd induction | Active comparator | All participants will receive standard of care treatment with daratumumab, lenalidomide, and dexamethasone for an initial 6 cycles. Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone |
| iFIT1 - DRd to PD | Active comparator | 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. Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone |
| iFIT1 - Daratumumab plus teclistamab (Dara-Tec) | Experimental | 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. Receives: Drug: Daratumumab; Drug: Teclistamab |
| iFIT1 - Daratumumab plus talquetamab (Dara-Tal) | Experimental | 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. Receives: Drug: Daratumumab; Drug: Talquetamab |
| iFIT2 - DRd to PD | Active comparator | 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. Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone |
| iFIT2 - DR to PD | Experimental | Participants assigned to the iFIT2 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease. Receives: Drug: Daratumumab; Drug: Lenalidomide |
| iFIT3 - DR to PD | Active comparator | Participants assigned to the iFIT3 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease. Receives: Drug: Daratumumab; Drug: Lenalidomide |
| iFIT3 - DR for 18 cycles | Experimental | 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. Receives: Drug: Daratumumab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2033 (estimated)
- Study completionJun 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- iFIT is a multi-centre, open-label, phase III platform trial with three randomised-controlled parallel-group components of transplant non-eligible (TNE) patients with newly diagnosed multiple myeloma
- Masking
- None (open label)
- Enrolment
- 1,226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Blood Cancer UK, Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Gordon Cook, Study chair, Leeds Institute of Clinical Trials ResearchCharlotte Pawlyn, Study chair, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649525
- Sponsor's protocol ID
- 1010810
- Acronym
- iFIT
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma
- ClinicalTrials.gov ID
- NCT07649525
- Acronym / sponsor ID
- iFIT / 1010810
- Conditions
- Multiple Myeloma (MM), Plasma Cell Leukemia (PCL)
- Keywords
- Myeloma, Platform adaptive design, Immunotherapy, Frailty, Personalised therapy, Biomarker-driven
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,226 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Cancer Research UK, Blood Cancer UK, Johnson & Johnson
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2033 (estimated)
- Study completion
- Jun 2037 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- iFIT is a multi-centre, open-label, phase III platform trial with three randomised-controlled parallel-group components of transplant non-eligible (TNE) patients with newly diagnosed multiple myeloma
| Arm | Type | Receives |
|---|---|---|
| DRd induction | Active comparator | Drug: Daratumumab, Drug: Lenalidomide, Drug: DexamethasoneAll participants will receive standard of care treatment with daratumumab, lenalidomide, and dexamethasone for an initial 6 cycles. |
| iFIT1 - DRd to PD | Active comparator | Drug: Daratumumab, Drug: Lenalidomide, Drug: DexamethasoneParticipants 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) | Experimental | Drug: Daratumumab, Drug: TeclistamabParticipants 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) | Experimental | Drug: Daratumumab, Drug: TalquetamabParticipants 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 comparator | Drug: Daratumumab, Drug: Lenalidomide, Drug: DexamethasoneParticipants 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 | Experimental | Drug: Daratumumab, Drug: LenalidomideParticipants 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 comparator | Drug: Daratumumab, Drug: LenalidomideParticipants 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 | Experimental | Drug: Daratumumab, Drug: LenalidomideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaratumumabAlso: D, DaraParticipants will receive daratumumab by subcutaneous injection. Each cycle is 28 days. | Drug | DRd induction, iFIT1 - DRd to PD, iFIT1 - Daratumumab plus talquetamab (Dara-Tal), iFIT1 - Daratumumab plus teclistamab (Dara-Tec), iFIT2 - DR to PD, iFIT2 - DRd to PD, iFIT3 - DR for 18 cycles, iFIT3 - DR to PD |
| LenalidomideAlso: R, RevlimidTaken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function. | Drug | DRd induction, iFIT1 - DRd to PD, iFIT2 - DR to PD, iFIT2 - DRd to PD, iFIT3 - DR for 18 cycles, iFIT3 - DR to PD |
| DexamethasoneAlso: dTaken as oral tablets, oral solution, or given by IV. Each cycle is 28 days. Dose can be adjusted for frailty and renal function. | Drug | DRd induction, iFIT1 - DRd to PD, iFIT2 - DRd to PD |
| TeclistamabAlso: TecParticipants will receive teclistamab by subcutaneous injection. Each cycle is 28 days. | Drug | iFIT1 - Daratumumab plus teclistamab (Dara-Tec) |
| TalquetamabAlso: TalParticipants will receive talquetamab by subcutaneous injection. Each cycle is 28 days. | Drug | iFIT1 - Daratumumab plus talquetamab (Dara-Tal) |
Primary outcome
iFIT1: Progression-free survival (PFS)
Time frame: From iFIT1 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
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.
iFIT2: Event-free survival (EFS)
Time frame: From iFIT2 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
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.
iFIT3: Progression-free survival (PFS) and participant-reported overall health and quality of life (QoL) - co-primary outcomes
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.
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.
19 secondary outcomes
Progression-free survival (PFS; iFIT2 only)
Time frame: From iFIT2 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
Time to progression (TTP)
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)
Time frame: From iFIT1/iFIT2/iFIT3 randomisation to PFS2 event, assessed up to a maximum of 10.5 years post-randomisation.
Overall survival (OS)
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)
Time frame: From iFIT1 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
Survival after progression
Time frame: From disease progression to death, assessed up to a maximum of 10.5 years post-randomisation.
Time to next treatment (TTNT)
Time frame: From registration to TTNT event, assessed up to a maximum of 10.5 years post-randomisation.
Overall response rate (ORR)
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
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
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
Time frame: From iFIT1/iFIT2/iFIT3 randomisation up to a maximum of 6.5 years post-randomisation.
Time to improved response
Time frame: From iFIT1/iFIT2/iFIT3 randomisation to first recorded improved response, up to a maximum of 6.5 years post-randomisation.
Treatment compliance
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
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
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
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
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Olivier contact
Gordon Cook study chair
Leeds Institute of Clinical Trials Research
Charlotte Pawlyn study chair
Institute of Cancer Research, United Kingdom
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daratumumab, Lenalidomide and Dexamethasone in people with Multiple Myeloma (MM) and Plasma Cell Leukemia (PCL), run by University of Leeds at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma McNaught (0113 343 1978, ctru-ifit@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iFIT1: Progression-free survival (PFS) (time frame: From iFIT1 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.