Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)

The goal of this clinical trial is to learn if anitocabtagene autoleucel following induction therapy works to treat adult participants with newly diagnosed multiple myeloma. The main objectives of this clinical trial are: * To determine the incidence and severity of all adverse events (AEs). * To determine the proportion of patients achieving undetectable minimal residual disease (uMRD) negative-CR rate (minimum 10 to -5) at 12 months (+/- 3 months) after enrollment. Participants will receive induction therapy with a quadruplet regimen including a proteasome inhibitor (Bortezomib \[V\]), immunomodulatory drug (Lenalidomide \[R\]), dexamethasone \[d\] and anti-CD38 monoclonal antibody (Daratumumab \[D\] or Isatuximab \[Isa\]) followed by anitocabtagene autoleucel. Participants in Cohorts A and B will receive lenalidomide maintenance therapy following infusion with anitocabtagene autoleucel.

NCT Number	NCT07045909
Lead Sponsor	PETHEMA Foundation
Conditions	De Novo Multiple Myeloma, Anitocabtagene Autoleucel
Enrollment	30 participants
Start Date	2025-06-30
Primary Completion	2028-03-31 (estimated)
Study Completion	2030-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-01