NCT06762769

Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smouldering Myeloma

Interventions

Type	Name	Description
DRUG	Isatuximab	Subcutaneous isatuximab will be delivered using an unlicensed medical device (On Body Delivery System)
DRUG	Iberdomide	Oral iberdomide
DRUG	Dexamethasone	Oral dexamethasone

Timeline

• Start date: 2025-06-02
• Primary completion: 2032-11-01
• Completion: 2032-11-01
• First posted: 2025-01-08
• Last updated: 2025-08-01

Locations

2 sites across 1 country: United Kingdom