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)

Overview

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 flow (NGF) or next generation sequencing (NGS) following high-dose therapy (HDT) and autologous stem cell transplant (ASCT), with or without consolidation therapy.

SparkCures ID 1013
Trial Phase Phase 3
Enrollment 214 Patients
Treatments
Trial Sponsors
  • Janssen Research & Development
NCT Identifier

NCT03901963

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Have newly diagnosed multiple myeloma with a history of 4 to 8 total cycles of induction with or without consolidation therapy and have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT): (a) for participants who have not received consolidation therapy, the participant must be within 180 days post-transplant at the time of randomization; and (b) for participants treated with consolidation therapy, the participant must be within 90 days of the last dose of consolidation therapy at the time of randomization
  • Must have a very good partial response (VGPR) or better response assessed per International Myeloma Working Group (IMWG) 2016 criteria at the time of randomization
  • Have archived bone marrow samples collected before induction treatment (that is, at diagnosis) or before transplant (for example, at the end of induction) or have existing results on the index multiple myeloma clone based on Adaptive Biotechnologies' next generation sequencing (NGS)-based minimal residual disease (MRD) assay. Archived bone marrow samples will be used for calibration of myeloma clonal cells to facilitate assessment of primary end point by NGS. If an existing result on index myeloma clone is available from Adaptive Biotechnologies' NGS-based MRD assay, as part of institutional procedures, an archived bone marrow sample is not required as long as Adaptive Biotechnologies is able to retrieve historical results on the index myeloma clone form the clinical database. Any one of the following archived samples are required: (a) Greater than 1 milliliter (mL) viable frozen bone marrow aspirated aliquot (preferred) collected in an ethylenediaminetetra-acetic acid (EDTA) tube, frozen, and stored at a temperature of −80 centigrade (°C), or; (b) Non-decalcified diagnostic bone marrow aspirate clot sections (block or slides) for MRD assessment: (i) A formalin fixed paraffin embedded (FFPE) block of bone marrow aspirate clot, or 5 slides, 5 micrometer each, of non-decalcified bone marrow, or (ii) 5 slides, bone marrow aspirate smear
  • Must have residual disease as defined by detectable MRD (Adaptive Biotechnologies' NGS based MRD assay)
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

Exclusion Criteria:

  • A history of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease before the of date of randomization. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
  • Have had prior treatment/therapy with: (a) Daratumumab or any other anti-cluster of differentiation 38 (CD38) therapies, (b) Focal radiation therapy within 14 days prior to randomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma. Radiotherapy within 14 days prior to randomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management, or (c) Plasmapheresis within 28 days of randomization
  • Be exhibiting clinical signs of meningeal or central nervous system involvement due to multiple myeloma
  • Have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (<) 50 percent (%) of predicted normal
  • Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
  • Have any of the following: (a) Known history of seropositivity for human immunodeficiency virus (HIV); (b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR; (c) Seropositive for hepatitis C (anti-hepatitis C virus [HCV] antibody positive or HCV-RNA quantitation positive), except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy)

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

SparkCures Verified Accurate, up-to-date information. Learn more


Reading Hospital and Medical Center

Reading, PA

SUNY Upstate Medical University State University of New York

Syracuse, NY

Allegheny Health Network (West Penn)

Pittsburgh, PA

Prisma Health Greenville Memorial Hospital

Greenville, SC

Prisma Health Spartanburg

Spartanburg, SC

Tennessee Oncology Memorial Plaza

Chattanooga, TN

Baptist Cancer Center Memphis

Mempis, TN

University of Washington School of Medicine

Seattle, WA

Summit Medical Group MD Anderson Cancer Center

Florham Park, NJ

Northwell Health Monter Cancer Center

Lake Success, NY

Miami Cancer Institute Baptist Health South Florida

Miami, FL

Cleveland Clinic Florida

Weston, FL

Blood and Marrow Transplantation Franciscan Health

Indianapolis, IN

Fort Wayne Medical Oncology and Hematology Fort Wayne North Office

Fort Wayne, IN

Norton Cancer Institute St. Matthews Campus

Louisville, KY

Henry Ford Hospital

Detroit, MI

Cancer and Hematology Centers of Western Michigan (Grand Rapids)

Grand Rapids, MI

Sarah Cannon Cancer Center at Research Medical Center

Kansas City, MO

University of Mississippi Medical Center

Jackson, MS

Forsyth Medical Center Novant Health

Winston-Salem, NC

Cancer Care Northwest (Sherman)

Spokane, WA

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Verified Alvin J. Siteman Cancer Center Washington University Medical Campus

SparkCures Verified Accurate, up-to-date information. Learn more


Arizona Oncology Associates

Glendale, AZ

MedStar Georgetown University Hospital

Washington, DC

Cancer Specialists of North Florida Southpoint

Jacksonville, FL

Illinois Cancer Specialists

Niles, IL

Ochsner Medical Center

Jefferson, LA

Presbyterian Hospital Novant Health

Charlotte, NC

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

New Brunswick, NJ

New York Oncology Hematology

Albany, NY

Montefiore Medical Center

Bronx, NY

NYU Winthrop Hospital

Mineola, NY

Oncology Hematology Care Inc. (Mercy West)

Cincinnati, OH

Northwest Cancer Specialists, PC

Tualatin, OR

Texas Oncology Austin Midtown

Austin, TX

Texas Oncology (Dallas)

Dallas, TX

Texas Oncology

Tyler, TX

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Virginia Oncology Associates Norfolk (Lake Wright)

Norfolk, VA

West Virginia University

Morgantown, WV

Alabama
Arizona
Arizona Oncology Associates

Glendale, AZ

California
Colorado
Connecticut
Florida
Cancer Specialists of North Florida Southpoint

Jacksonville, FL

Miami Cancer Institute Baptist Health South Florida

Miami, FL

Cleveland Clinic Florida

Weston, FL

Illinois
Illinois Cancer Specialists

Niles, IL

Indiana
Fort Wayne Medical Oncology and Hematology Fort Wayne North Office

Fort Wayne, IN

Blood and Marrow Transplantation Franciscan Health

Indianapolis, IN

Kansas
Kentucky
Norton Cancer Institute St. Matthews Campus

Louisville, KY

Louisiana
Ochsner Medical Center

Jefferson, LA

Maryland
Massachusetts
Michigan
Henry Ford Hospital

Detroit, MI

Cancer and Hematology Centers of Western Michigan (Grand Rapids)

Grand Rapids, MI

Mississippi
University of Mississippi Medical Center

Jackson, MS

Missouri
Verified Alvin J. Siteman Cancer Center Washington University Medical Campus

SparkCures Verified Accurate, up-to-date information. Learn more


Sarah Cannon Cancer Center at Research Medical Center

Kansas City, MO

New Jersey
Summit Medical Group MD Anderson Cancer Center

Florham Park, NJ

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

New Brunswick, NJ

New York
New York Oncology Hematology

Albany, NY

Montefiore Medical Center

Bronx, NY

Northwell Health Monter Cancer Center

Lake Success, NY

NYU Winthrop Hospital

Mineola, NY

SUNY Upstate Medical University State University of New York

Syracuse, NY

North Carolina
Verified UNC Lineberger Comprehensive Cancer Center University of North Carolina
Verified Wake Forest Baptist Comprehensive Cancer Center Wake Forest School of Medicine

SparkCures Verified Accurate, up-to-date information. Learn more


Presbyterian Hospital Novant Health

Charlotte, NC

Forsyth Medical Center Novant Health

Winston-Salem, NC

Ohio
Oncology Hematology Care Inc. (Mercy West)

Cincinnati, OH

Oregon
Northwest Cancer Specialists, PC

Tualatin, OR

Pennsylvania
Allegheny Health Network (West Penn)

Pittsburgh, PA

Reading Hospital and Medical Center

Reading, PA

South Carolina
Prisma Health Greenville Memorial Hospital

Greenville, SC

Prisma Health Spartanburg

Spartanburg, SC

Tennessee
Tennessee Oncology Memorial Plaza

Chattanooga, TN

Baptist Cancer Center Memphis

Mempis, TN

Texas
Texas Oncology Austin Midtown

Austin, TX

Texas Oncology (Dallas)

Dallas, TX

Texas Oncology

Tyler, TX

Utah
Virginia
UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Virginia Oncology Associates Norfolk (Lake Wright)

Norfolk, VA

Washington
University of Washington School of Medicine

Seattle, WA

Cancer Care Northwest (Sherman)

Spokane, WA

Washington, D.C.
MedStar Georgetown University Hospital

Washington, DC

West Virginia
West Virginia University

Morgantown, WV

Resources

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