REALIZENCT07889323

REAL World IMROZ OutcomEs (REALIZE Study)

StatusNot Yet Recruiting

PhaseNot specified

SponsorThe Royal Wolverhampton Hospitals NHS Trust

Primary completionDec 2028 (estimated)

At risk: Primary endpoint(s) modified.

See at-risk trials from The Royal Wolverhampton Hospitals NHS Trust

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 5, 2026 Primary endpoint(s) modified
- Eligibility criteria expanded, about 57 words
- Secondary endpoints: 1 to 2
Oct 15, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Responses

Timeframe: within 12 months

Treatment discontinuation rate

Timeframe: within 12 months of receiving their first dose of Isa-VRD

Relative Dose Intensity

Timeframe: within 12 months of receiving their first dose of Isa-VRD

Progression-Free Survival

Timeframe: 12-months from their first dose of Isa-VRD

Overall Survival

Timeframe: 12 months from their first dose of Isa-VRD

Rate of PRD negativity

Timeframe: 12-months from the start of Isa-VRD

Proportion of patients maintaining sustained PRD-negative status

Timeframe: 24-months from the start of Isa-VRD

Secondary (2)

Number and Percentage of PRD Substudy Participants with a Negative EXENT GAM Assay at 12 Months

Number and Percentage of PRD Substudy Participants Maintaining EXENT GAM Assay Negativity for 12 Months

About this trial

Demonstrating the real-world effectiveness of Isa-VRD in routine NHS care is the key aim for this proposal Isatuximab (Isa) is an IgG1 monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumour activity via multiple mechanisms of action. In the Phase 3 multicentre randomised study IMROZ, Isa in combination with velcade, lenalidomide and dexamethasone (VRD) was compared to VRD in transplant-ineligible (TIE) patient with newly diagnosed multiple myeloma (MM). In the UK however, bone marrow (BM)-based MRD testing is not routinely available and poorly utilised in everyday practice. Limited access, the need for repeated invasive procedures, and service capacity constraints hinder widespread, longitudinal BM MRD assessment - particularly for TIE, newly diagnosed MM patients treated outside of specialised centres. As a result, routine monitoring often relies on conventional serum tests (serum protein electrophoresis, immunofixation electrophoresis and serum free light chain assays), which lack the analytical sensitivity to consistently detect very low-level disease.

Trial details

Enrollment: 150 participants (estimated)
Started: Dec 2026
Study completion: Dec 2028 (estimated)
Eligibility: 75 and older, all sexes
Design: Observational
Conditions: Newly Diagnosed Multiple Myeloma (NDMM)
Collaborators: Oxford University Hospitals NHS Trust
First posted: Oct 22, 2026
Registry updated: Nov 10, 2026
Last verified: Nov 2026

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