MedTrace Logo

Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma

NCT06762769 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-08-01

No results posted yet for this study

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

DRUG

Isatuximab

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

DRUG

Iberdomide

Oral iberdomide

DRUG

Dexamethasone

Oral dexamethasone

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Bristol Myers Squibb Pharmaceuticals Limited

    collaborator UNKNOWN

  • University College, London

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2032-11-30
Completion
2032-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06762769 on ClinicalTrials.gov