RecruitingPhase 2NCT06762769

Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma


Sponsor

University College, London

Enrollment

63 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study will test a new combination of 3 drugs: Isatuximab (Isa), Iberdomide (Iber) and Dexamethasone (Dex), in patients who have intermediate or high risk smouldering myeloma. Smouldering myeloma is an early form of myeloma which may progress to active multiple myeloma, but at a slow rate. Patients with smouldering myeloma do not usually receive any treatment but will have regular check-ups and observation. Some patients have a diagnosis of smouldering myeloma which has a higher risk of progressing to active myeloma. The study will test if the combination of drugs is effective at preventing or delaying the disease progressing into active multiple myeloma. The study will also test if the combination is tolerated and accepted by patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two immunotherapy drugs — isatuximab and iberdomide — in people with smouldering multiple myeloma (SMM), a pre-cancerous blood condition that has a high risk of progressing to full multiple myeloma. The goal is to see whether early treatment can delay or prevent progression. **You may be eligible if...** - You are 18 or older - You have been diagnosed with smouldering multiple myeloma within the past 5 years - Your SMM is classified as intermediate or high risk, and that classification was made within the last 2 years - You have not yet developed full-blown multiple myeloma requiring treatment **You may NOT be eligible if...** - Your SMM has already progressed to active multiple myeloma - You have other health conditions that make this treatment unsafe - You have already received treatment for your myeloma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIsatuximab

Subcutaneous isatuximab will be delivered using an unlicensed medical device (On Body Delivery System)

DRUGIberdomide

Oral iberdomide

DRUGDexamethasone

Oral dexamethasone


Locations(2)

Barts Health Trust

London, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06762769