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

EU record number

68284528MMY2001

EudraCT number

2018-001023-38

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

Pharmaceutical study code

bb2121

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