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

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

Trial Details

NCT ID
NCT06216158
Phase
PHASE3
Sponsor
University of Heidelberg Medical Center
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Iberdomide
  • Isatuximab
  • Dexamethasone
Locations (sample)
  • Krems, Austria|48.40921,15.61415
  • Linz, Austria|48.30639,14.28611
  • Salzburg, Austria|47.79941,13.04399
  • Vienna, Austria|48.20849,16.37208
  • Wels, Austria|48.16667,14.03333

Key Eligibility Criteria

  • Prior inclusion and treatment within the GMMG-HD8 / DSMM XIX trial OR
  • Received a quadruplet induction/consolidation therapy that consists of a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) \[e.g., bortezo…
  • Post HDM/ASCT consolidation containing similar substances as induction therapy is permitted
  • Induction and consolidation therapy should make up a total of at least 4 up to 6 cycles, with a maximum of 2 consolidation cycles post HDM/ASCT AND

For full eligibility, visit ClinicalTrials.gov.

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