drugset / Trial / NCT06216158
Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma
Phase 3
Recruiting
411 enrolled
University of Heidelberg Medical Center
Bristol-Myers Squibb · collabKKS Netzwerk · collabSanofi · collabWuerzburg University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to compare a maintenance therapy consisting of iberdomide and isatuximab with an iberdomide-only regimen. The trial is the subsequent maintenance therapy to GMMG-HD8/DSMM XIX trial for patients with newly-diagnosed multiple myeloma. Patients with newly-diagnosed multiple myeloma who underwent a similar quadruplet induction/consolidation therapy regimen followed by at least one ASCT can also be recruited. The main question it aims to answer is: • Will the addition of isatuximab lead to decreased amounts of measurable myeloma cells in the bone marrow after two years?
Timeline
- Start
- 2024-04-05
- Primary completion
- 2028-12
- Completion
- 2029-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iberdomide | Small molecule | 0.75 mg | Oral |
| Subject | Isatuximab | Monoclonal antibody | 1400 mg | Subcutaneous |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |