A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)

Phase 1 Completed 50 enrolled Takeda

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen. The purpose of the safety/access cohort is to provide continued access to TAK-079 to participants previously enrolled to a TAK-079 parent study and to evaluate the long-term safety profile of TAK-079.

Timeline

Start: 2019-07-29
Primary completion: 2026-03-25
Completion: 2026-03-25

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mezagitamab	Monoclonal antibody	—	Subcutaneous
Background	Bortezomib	Small molecule	—	Subcutaneous
Background	Dexamethasone	Small molecule	—	Oral
Background	Lenalidomide	Other / unclassified	—	Oral
Background	Pomalidomide	Other / unclassified	—	Oral

A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)

Summary

Timeline

Drugs

Indications