- Active, not recruiting
NCT03901963: Phase 3 - Dara + Len vs Len as Maint. in New Myeloma +MRD after frontline ASCT (AURIGA)
Updated: Feb 10
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)
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
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
Drug: Daratumumab
Drug: Lenalidomide
MRD Testing
Daratumumab - FDA Approved Drugs Multiple Myeloma (themyelomaclinicaltrials.com) Revlimid (lenalidomide) - FDA Approved Drugs Multiple Myeloma (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