NCT03984097: Phase 1: A Study to Evaluate Subcutaneous TAK-079 Added to Standard Regimens NDMM

NCT03984097: Phase 1: A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)

NCT03984097: Phase 1: A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)

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.

Sponsor:

Takeda

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ClinicalTrials.gov Identifier: NCT03984097

Official Title: 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

First Posted : June 12, 2019

Click here to see details on ClinicalTrials.gov

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Drug: TAK-079

Drug: Lenalidomide

Drug: Dexamethasone

Drug: Bortezomib

Drug: Pomalidomide

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TAK-079

Mezagitamab (Code C148078)

Anti-CD38 MAb TAK-079

Mezagitamab

MEZAGITAMAB

TAK 079

TAK-079

TAK079

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Locations

United States, Alabama

United States, California

United States, Maryland

United States, New York

United States, North Carolina

United States, Ohio

United States, Oregon

United States, Texas

United States, Wisconsin