Clinical Trial

Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma

Recruiting Phase 3
View on ClinicalTrials.gov →
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?
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-01-19; most recent amendment 2026-01-29.
Status change: Not Yet Recruiting → Recruiting 2024-04-08
Trial Details
NCT Number NCT06216158
Lead Sponsor University of Heidelberg Medical Center
Collaborators: KKS Netzwerk, Wuerzburg University Hospital, Sanofi, Bristol-Myers Squibb
Conditions Multiple Myeloma
Enrollment 411 participants
Start Date 2024-04-05
Primary Completion 2028-12 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-02