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