Long title
A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide Refractory Multiple Myeloma
Date receipt dossier
EU record number
68284528MMY2003
EudraCT number
2019-004317-14
Company / Sponsor
Janssen-Cilag International NV
Phase
III
Treated organism
Humans
Indication category
Cancer therapy
Disease
relapsed and lenalidomide refractory multiple myeloma
Therapeutic approach
Immunotherapy
Genetic modification
Autologous T cells expressing BCMA (B-cell maturation antigen)-CAR
Method of transfer of nucleic acid of interest
Lentiviral vector
Administered biological material
Autologous T cells transduced with lentiviral vectors expressing BCMA (B-cell maturation antigen)-CAR
Route of administration
Intravenous
Locations in Belgium
UZ Antwerpen, UZ Leuven, U Gent
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
JNJ-68284528