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

Sponsor
University of Leeds
Study ID
NCT07649525
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Multiple Myeloma (MM)
  • Plasma Cell Leukemia (PCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
  • Lenalidomide — DRUG
    Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
  • Dexamethasone — DRUG
    Taken as oral tablets, oral solution, or given by IV. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
  • Teclistamab — DRUG
    Participants will receive teclistamab by subcutaneous injection. Each cycle is 28 days.
  • Talquetamab — DRUG
    Participants will receive talquetamab by subcutaneous injection. Each cycle is 28 days.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
May 31, 2033
Completion
May 31, 2037

Study Design

Enrollment
1,226 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: DRd induction
    All participants will receive standard of care treatment with daratumumab, lenalidomide, and dexamethasone for an initial 6 cycles.
  • Active Comparator: iFIT1 - DRd to PD
    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.
  • Experimental: iFIT1 - Daratumumab plus teclistamab (Dara-Tec)
    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.
  • Experimental: iFIT1 - Daratumumab plus talquetamab (Dara-Tal)
    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.
  • Active Comparator: iFIT2 - DRd to PD
    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.
  • Experimental: iFIT2 - DR to PD
    Participants assigned to the iFIT2 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.
  • Active Comparator: iFIT3 - DR to PD
    Participants assigned to the iFIT3 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.
  • Experimental: iFIT3 - DR for 18 cycles
    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.

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. ]

Central Contacts

Related Studies