REAL World IMROZ OutcomEs (REALIZE Study)

NCT07889323 | Not Yet Recruiting

• 1 other identifier: 2026HAE152
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Newly Diagnosed Multiple Myeloma (NDMM)

Outcome Measures

Primary Outcomes (7)

• Responses

  Responses will be evaluated using the IMWG 2016 uniform response criteria and the ORR will be calculated by evaluating the number and proportion of patients who achieve ≥partial response

  within 12 months

• Treatment discontinuation rat

  Treatment discontinuation rate at 12 months will be analysed by collecting data on the number and proportion of patients who discontinued treatment within 12 months of receiving their first dose of Isa-VRD

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

• Relative Dose Intensity

  RDI within the first 12 months of treatment for each agent within Isa-VRD will be calculated by collecting the number and dose of each treatment delivered within the 12 month timeframe following their firs dose of Isa-VRD. Data on renal function will also be collected to ensure the lenalidomide dose intensity is calculated taking into account the adjusted dosing schedule for lenalidomide according to the summary of product characteristics for lenalidomide (7)

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

• Progression-Free Survival

  12-month PFS will be calculated as the proportion of patients alive and progression free at 12-months from their first dose of Isa-VRD

  12-months from their first dose of Isa-VRD

• Overall Survival

  12-month OS defined as the proportion patients alive at 12 months from their first dose of Isa-VRD

  12 months from their first dose of Isa-VRD

• Rate of PRD negativity

  Rate of PRD negativity, as defined by EXENT GAM assay negativity, will be assessed at 12-months from the start of Isa-VRD

  12-months from the start of Isa-VRD

• Proportion of patients maintaining sustained PRD-negative status

  Proportion of patients maintaining sustained PRD-negative status for a minimum duration of 12 months, will be assessed by evaluating how many patients who are PRD-negative at 12-months from initiation of Isa-VRD remain PRD-negative at 24-months from the start of Isa-VRD

  24-months from the start of Isa-VRD

Secondary Outcomes (1)

• Peripheral Residual Disease sub study

  12 months from start of Isa-VRD

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 in main study, and 100 in the substudy

You may qualify if:

• a. sIMWG frailty score b. Patients with and without eGFR \<30 ml/minute/1.73 m2 c. Deprivation score and ethnicity d. Age ≥75 and/or sIMWG frailty score ≥2

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead
• Oxford University Hospitals NHS Trust: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 22, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 22, 2026

Record last verified: 2026-10