Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma

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.

NCT Number	NCT06762769
Lead Sponsor	University College, London Collaborators: Sanofi, Bristol Myers Squibb Pharmaceuticals Limited
Conditions	Smouldering Myeloma
Enrollment	63 participants
Start Date	2025-06-02
Primary Completion	2032-11 (estimated)
Study Completion	2032-11 (estimated)
Updated on ClinicalTrials.gov	2025-08-01