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 R

Study 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 R
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: 
21 Dec 2018
EU record number: 
68284528MMY2003
EudraCT number: 
2019-004317-14
Pharmaceutical study code: 
JNJ-68284528
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