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
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What's the purpose of this trial?

The purpose of this clinical trial is to compare the use of an investigational medicine and lenalidomide vs. lenalidomide alone as maintenance in patients with newly diagnosed multiple myeloma who are minimal residual disease positive after an autologous stem cell transplant.

This trial is currently open and accepting patients.

What will happen during the trial?

Participants in this study will be randomly assigned to one of two groups (also called arms). Participants in Arm A will receive daratumumab and lenalidomide, while participants in Arm B will receive lenalidomide alone.

Participants in either arm will receive their therapies in 28 day cycles, and may receive up to 36 cycles as long as their myeloma doesn’t get worse or they don’t experience bad side effects.

ARM A

  • Participants will receive daratumumab by a subcutaneous injection weekly during cycles 1 and 2, every two weeks during cycles 3-6, and every four weeks from cycle 7 onwards.
  • Participants will receive lenalidomide by mouth daily. After three cycles, if lenalidomide is well tolerated, the dose may be increased at the discretion at the study doctor.

ARM B

  • Participants will receive lenalidomide by mouth daily. After three cycles, if lenalidomide is well tolerated, the dose may be increased at the discretion at the study doctor.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

  • Have newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy and autologous stem cell transplant within 12 months of the start of induction therapy, and be within 6 months of the date of autologous stem cell transplant at the time of randomization
  • Patient must have minimal residual disease (MRD) as defined by Adaptive Biotechnologies’ NGS-based (MRD) assay
  • Patient must have not had prior treatment with daratumumab or any other anti-CD-38 therapies
  • Patient must not have had radiation therapy within 14 days of joining the study
  • Patient must not have evidence of central nervous system myeloma involvement

Additional Trial Information

Phase 3

Enrollment: 214 patients (estimated)

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Trial Locations

All Trial Locations

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Alabama

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center at UAB

Birmingham, AL

Open and Accepting

Arizona

Arizona Oncology Associates

Glendale, AZ

Open and Accepting

Cancer Treatment Centers of America - Phoenix

Goodyear, AZ

Open and Accepting

California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco

San Francisco, CA

Open and Accepting

Moores Cancer Center UC San Diego Health

La Jolla, CA

Open and Accepting

UCLA Jonsson Comprehensive Cancer Center University of California Los Angeles

Los Angeles, CA

Open and Accepting

Colorado

Rocky Mountain Cancer Centers - Denver Midtown Denver - Midtown

Denver, CO

Open and Accepting

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

University of Colorado Health - Poudre Valley Hospital Poudre Valley Hospital

Fort Collins, CO

Open and Accepting

Connecticut

Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven

New Haven, CT

Open and Accepting

Florida

Cancer Specialists of North Florida - Southpoint Southpoint

Jacksonville, FL

Open and Accepting

Miami Cancer Institute Baptist Health South Florida

Miami, FL

Open and Accepting

Sylvester Comprehensive Cancer Center University of Miami Health System

Miami, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Cleveland Clinic Florida

Weston, FL

Open and Accepting

Georgia

University Cancer and Blood Center

Athens, GA

Open and Accepting

Illinois

Illinois Cancer Specialists

Niles, IL

Open and Accepting

Cancer Treatment Centers of America - Chicago Midwestern Regional Medical Center

Zion, IL

Open and Accepting

Indiana

Fort Wayne Medical Oncology and Hematology (Fort Wayne North) Fort Wayne North Office

Fort Wayne, IN

Open and Accepting

Franciscan Health Cancer Center Indianapolis

Indianapolis, IN

Open and Accepting

Louisiana

Ochsner Medical Center

Jefferson, LA

Open and Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, MD

Open and Accepting

Massachusetts

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Michigan

Henry Ford Hospital

Detroit, MI

Open and Accepting

Cancer and Hematology Centers of Western Michigan - East

Grand Rapids, MI

Open and Accepting

Mississippi

University of Mississippi Medical Center

Jackson, MS

Open and Accepting

Missouri

Sarah Cannon Cancer Center at Research Medical Center

Kansas City, MO

Open and Accepting

New Jersey

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Open and Accepting

New York

Montefiore Medical Center

Bronx, NY

Open and Accepting

Northwell Health Monter Cancer Center

Lake Success, NY

Open and Accepting

NYU Winthrop Hospital

Mineola, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, NY

Open and Accepting

SUNY Upstate Medical University State University of New York

Syracuse, NY

Open and Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina

Chapel Hill, NC

Open and Accepting

Wake Forest Baptist Comprehensive Cancer Center Wake Forest School of Medicine

Winston-Salem, NC

Open and Accepting

Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting

Novant Health Presbyterian Medical Center Novant Health

Charlotte, NC

Open and Accepting

Novant Health Forsyth Medical Center - Silas Creek

Winston-Salem, NC

Open and Accepting

Ohio

Oncology Hematology Care Inc. (Mercy West)

Cincinnati, OH

Open and Accepting

Oregon

Oregon Health and Science University (OHSU) Knight Cancer Institute

Portland, OR

Open and Accepting

Pennsylvania

Fox Chase Cancer Center Temple Health

Philadelphia, PA

Open and Accepting

West Penn Hospital (Allegheny Health Network)

Pittsburgh, PA

Open and Accepting

UPMC Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Open and Accepting

Tower Health Reading Hospital

West Reading, PA

Open and Accepting

South Carolina

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, SC

Open and Accepting

Prisma Health - Greenville Memorial Hospital

Greenville, SC

Open and Accepting

Tennessee

Baptist Cancer Center Memphis

Mempis, TN

Open and Accepting

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

Texas Oncology (Austin Midtown) Austin Midtown

Austin, TX

Open and Accepting

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Open and Accepting

Texas Oncology (Dallas)

Dallas, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

UT Health San Antonio MD Anderson Cancer Center Mays Cancer Center

San Antonio, TX

Open and Accepting

Texas Oncology

Tyler, TX

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting

Virginia

Virginia Cancer Specialists

Fairfax, VA

Open and Accepting

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting

Virginia Oncology Associates - Lake Wright Norfolk (Lake Wright)

Norfolk, VA

Open and Accepting

Washington

VA Puget Sound Health Care System

Seattle, WA

Open and Accepting

University of Washington School of Medicine

Seattle, WA

Open and Accepting

Washington, D.C.

MedStar Georgetown University Hospital

Washington, DC

Open and Accepting
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