• Recruiting

NCT03901963: Phase 3 - Dara + Len vs Len as Maint. in New Myeloma +MRD after frontline ASCT (AURIGA)

Updated: Sep 15

AURIGA Study


A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant (AURIGA)


AURIGA study

The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-cluster of differentiation 38 (CD38) treatment naive participants with newly diagnosed multiple myeloma who are MRD positive as determined by next generation sequencing (NGS) at screening, following high-dose therapy (HDT) and autologous stem cell transplant (ASCT).


A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant (AURIGA)


Sponsor

Janssen Research & Development, LLC


Multiple Locations

International Study

 

ClinicalTrials.gov Identifier: NCT03901963

Official Title: A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

First Posted: April 3, 2019

Click here for details on ClinicalTrials.gov

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

 

Drug: Daratumumab

Drug: Lenalidomide

 

MRD Testing

Adaptive Biotechnologies

Minimal Residual Disease (MRD) | Patient Education (themyelomaclinicaltrials.com)

 

Daratumumab - FDA Approved Drugs Multiple Myeloma (themyelomaclinicaltrials.com) Revlimid (lenalidomide) - FDA Approved Drugs Multiple Myeloma (themyelomaclinicaltrials.com)

Transplant in Multiple Myeloma | Patient Education (themyelomaclinicaltrials.com)

 

- Alabama: University of Alabama at Birmingham

- California: University of California San Diego

- Colorado: Sarah Cannon/Colorado Blood Cancer Institute Denver

- Connecticut: Yale University New Haven

- Florida: Miami Cancer Institute

- Florida: Moffitt Cancer Center Tampa

- Florida: Sylvester Comprehensive Cancer Center - University of Miami

- Florida: Moffitt Cancer Center Tampa

- Iowa: University of Iowa Iowa city

- Minnesota: Mayo Clinic Rochester Minnesota

- Missouri: Washington University School of Medicine Saint Louis

- New Jersey: Rutgers Cancer Institute of New Jersey New Brunswick

- New York: Columbia University Medical Center New York

- New York: Tisch Cancer Institute Mount Sinai Hospital New York

- New York: University of Rochester New York

- North Carolina: Levine Cancer Institute Charlotte

- North Carolina: Wake Forest Baptist Health Winston-Salem

- Pennsylvania: Fox Chase Cancer Center Philadelphia

- Pennsylvania: University of Pittsburgh Medical Center

- Texas: UT Southwestern Medical Center Dallas

- Texas: The University of Texas MD Anderson Cancer Center Houston

 

Locations


United States, Alabama

United States, Arizona

United States, California

United States, Colorado

United States, Connecticut

United States, District of Columbia

United States, Florida

United States, Georgia

United States, Illinois

United States, Indiana

United States, Iowa

United States, Kansas

United States, Kentucky

United States, Louisiana

United States, Maryland

United States, Massachusetts

United States, Michigan

United States, Minnesota

United States, Mississippi

United States, Missouri

United States, New Jersey

United States, New York

United States, North Carolina

United States, Ohio

United States, Oregon

United States, Pennsylvania

United States, South Carolina

United States, Tennessee

United States, Texas

United States, Utah

United States, Virginia

United States, Washington


Canada

Canada, Ontario

Canada, Quebec

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