REAL World IMROZ OutcomEs (REALIZE Study)

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Planned participants: 150
• From Dec 2026 to the primary completion date, Dec 2028
• No sites listed in no country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 75 years to - · Sex: All

Full criteria on ClinicalTrials.gov