Study title:
A phase III, multicenter, randomized, open-label study to compare the efficacy and safety of bb2121 versus standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM) (KarMMa-3)
Long title:
A phase III, multicenter, randomized, open-label study to compare the efficacy and safety of bb2121 versus standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM) (KarMMa-3)
Date receipt dossier:
3 okt 2017
EU record number:
68284528MMY2001
EudraCT number:
2018-001023-38
Pharmaceutical study code:
bb2121
Company / Sponsor:
Celgene
Phase:
III
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
relapsed or refractory multiple myeloma
Therapeutic approach:
Immunotherapy
Genetic modification:
BCMA02 (human B cell maturation antigen) -Chimeric antigen receptor
Method of transfer of nucleic acid of interest:
Lentiviral vectors
Administered biological material:
Autologous T-cells transduced with lentiviral vectors expressing BCMA02 (human B cell maturation antigen)-chimeric antigen receptor
Route of administration:
Intravenous
Locations in Belgium:
UZ Leuven
Type of procedure:
Contained use only
Current status:
Authorized