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NCT01564537: Phase 3 - TOURMALINE-MM1 - Oral Ixazomib + Len/Dex Vs Placebo + Len/Dex RRMM

Updated: Oct 4, 2022

TOURMALINE-MM1


A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

TOURMALINE MM1 trial

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma


The purpose of this study is to determine whether the addition of oral ixazomib to the background therapy of lenalidomide and dexamethasone improves progression free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM).


Sponsor

Millennium Pharmaceuticals, Inc.


Information provided by (Responsible Party)

Takeda ( Millennium Pharmaceuticals, Inc. )

 

ClinicalTrials.gov Identifier: NCT01564537

Official Title: A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

First Posted : March 28, 2012

Click here for details on ClinicalTrials.gov

 

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

Ixazomib: National Cancer Institute

Ixazomib: MedlinePlus Drug Information

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

 

Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.

N Engl J Med. 2016


Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients.

Blood. 2017 Dec


Impact of prior therapy on the efficacy and safety of oral ixazomib-lenalidomide-dexamethasone vs. placebo-lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in TOURMALINE-MM1.

Haematologica. 2017 Oct


Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study.

J Hematol Oncol. 2017

 

Drug: Ixazomib

Drug: Lenalidomide

Drug: Dexamethasone

Drug: Placebo

 

- Arkansas: University of Arkansas Little Rock

- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston

- Minnesota: Mayo Clinic Rochester Minnesota

- New Jersey: Hackensack University Medical Center

- New York: Columbia University Medical Center New York

- New York: Roswell Park Cancer Institute Buffalo

- Wisconsin: Medical College Of Wisconsin Milwaukee

- Washington: Fred Hutchinson Cancer Center Seattle

 

Locations

United States, Arkansas

United States, California

United States, Florida

United States, Georgia

United States, Illinois

United States, Massachusetts

United States, Minnesota

United States, New Jersey

United States, New York

United States, North Carolina

United States, Pennsylvania

United States, South Carolina

United States, Washington

United States, West Virginia

United States, Wisconsin

Canada, Alberta

Canada, British Columbia

Canada, New Brunswick

Canada, Quebec

 

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