• Active, not recruiting

NCT02312258: Phase 3: TOURMALINE-MM4 - Oral Ixazomib Maintenance Therapy in NDMM-TIE

Updated: Oct 4

TOURMALINE-MM4 Trial


NCT02312258: Phase 3: A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

tourmaline-mm4

NCT02312258: Phase 3: A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)


The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.


Sponsor

Takeda

 

ClinicalTrials.gov Identifier: NCT02312258

Official Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

First Posted: December 9, 2014

Click here for details on ClinicalTrials.gov

 

Ixazomib: National Cancer Institute

Ixazomib: MedlinePlus Drug Information

 

Drug: Placebo

Drug: Ixazomib

 

MRD dynamics during maintenance for improved prognostication of 1280 myeloma patients in TOURMALINE-MM3 and -MM4 trials

Blood;2022 Sep 21

Click here for details


Intenational Myeloma Foundation: Measurable Residual Disease Evaluation During Ixazomib Maintenance in NDMM: TOURMALINE-MM3 and -MM4

Jun 16, 2021

Click here for details


Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial

J Clin Oncol; 2020

Click here for details

 

Locations

United States, California

United States, Georgia

United States, Illinois

United States, Iowa

United States, Kentucky

United States, Maine

United States, Maryland

United States, Massachusetts

United States, Michigan

United States, New York

United States, North Carolina

United States, Pennsylvania

United States, Texas

United States, Washington

United States, West Virginia

Argentina

Australia, Victoria

Austria

Belgium

Brazil

Canada, Ontario

Canada, Quebec

Asia

Europe

Chile

China, Jiangsu

China, Shanghai

China, Zhejiang

China

Colombia

Croatia

Czechia

Denmark

France

Germany

Greece

Hungary

Israel

Italy

Japan

Korea, Republic of

Mexico

Poland

Portugal

Russian Federation

Serbia

Singapore

South Africa

Spain

Sweden

Switzerland

Taiwan

Thailand

Turkey

United Kingdom

 

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