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)

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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 oct 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