Study 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 (N
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:
22 Sep 2023
EudraCT number:
2022-501346-30
Pharmaceutical study code:
Ide-Cel (bb2121)
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