Long title
A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel (Ide-Cel) with Lenalidomide (LEN) Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants with Newly Diagnosed Multiple Myeloma (NDMM) Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9
Date receipt dossier
EudraCT number
2022-501346-30
Company / Sponsor
Celgene
Phase
III
Treated organism
Humans
Indication category
Cancer therapy
Disease
Multiple myeloma
Therapeutic approach
Immunotherapy
Genetic modification
BCMA CAR
Method of transfer of nucleic acid of interest
Lentiviral vector
Administered biological material
Autologous T cells transduced with lentiviral vectors expressing BCMA-CAR
Route of administration
Intravenous
Locations in Belgium
Institut Jules Bordet, UZ Brussel
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
Ide-Cel (bb2121)