An Open-Label, Multicenter Phase 1b Study Investigating the Safety of TAK-079 in Combination with Backbone Regimens for the Treatment of Patients with Newly Diagnosed Multiple Myeloma and for Whom Stem Cell Transplantation Is Not Planned as Initial Therapy

Protocol No
TAKEDA-TAK-079-1002
Principal Investigator
Anita D'Souza
Phase
I
Summary
TAK-079 is a monoclonal antibody (a type of protein made in the laboratory that can bind to substances in the body, including cancer cells) that works in several ways. One way this monoclonal antibody works is by attaching itself to multiple myeloma cells in your body and directly killing them and/or allowing your immune system to destroy them. TAK-079 targets and attaches to a protein called CD38, which is present in high numbers on multiple myeloma cells. CD38 is also present in lower numbers on other certain cell types and may affect them.
Description
The main purpose of this study is to obtain information on the best dose of the research drug, TAK 079, when administered in combination with the backbone treatment regimens.

If you are eligible to participate in this study, you will be assigned to receive either:
1) Arm A: TAK-079 (study medication), lenalidomide and dexamethasone (backbone regimen)
or
2) Arm B: TAK-079 (study medication), bortezomib, lenalidomide and dexamethasone (backbone regimen)
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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