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

Recruiting Phase 3 Interventional Study
Multiple Myeloma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
411 (estimated)
Sponsor
University of Heidelberg Medical Center · Other
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About This Trial
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 b…
Trial Locations
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Eligibility Criteria
Inclusion 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., bortezomib, thalidomide and dexamethasone, or bortezomib, lenalid…
Contacts

Hartmut Goldschmidt, Prof.

+49 6221 568198

s.gmmg@med.uni-heidelberg.de

CONTACT