Clinical Research Directory

REAL World IMROZ OutcomEs (REALIZE Study)

Sponsor: The Royal Wolverhampton Hospitals NHS Trust

Summary

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.

Key Details

Conditions