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 60 to 100 days post-transplant at the time of randomization; and (b) for participants treated with consolidation therapy, the participant must be within 60 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 biopsy samples collected before induction treatment (that is, at diagnosis) or before transplant (for example, at the end of induction). Archived bone marrow samples will be used for calibration of myeloma clonal cells to facilitate assessment of primary end point by next generation sequencing (NGS). 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 tissue for minimal residual disease (MRD) assessment: (i) 5 slides, 5 micrometer each, of non-decalcified bone marrow, or (ii) 5 slides, 5 micrometer each, bone marrow aspirate smear
  • Must have residual disease as defined by detectable MRD by next generation flow (NGF) assay
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

Exclusion Criteria:

  • Have peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
  • Have any prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, and concurrence by the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
  • Have had prior treatment/therapy with: (a) Anti-cluster of differentiation 38 (CD38) antibody at any time, (b) Radiation within 14 days of randomization, 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) Seropositive 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.

Fort Wayne Medical Oncology and Hematology
Fort Wayne North Office

Fort Wayne, IN

Norton Cancer Institute
St. Matthews Campus

Louisville, KY

Cancer and Hematology Centers of Western Michigan (Grand Rapids)

Grand Rapids, MI

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.

Miami Cancer Institute
Baptist Health South Florida

Miami, FL

Cleveland Clinic Florida

Weston, FL

Siouxland Hematology Oncology Associates

Sioux City, IA

Blood and Marrow Transplantation
Franciscan Health

Indianapolis, IN

Ochsner Medical Center

Jefferson, LA

University of Mississippi Medical Center

Jackson, MS

University of North Carolina
Lineberger Comprehensive Cancer Center

Chapel Hill, NC

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

Northwell Health
Monter Cancer Center

Lake Success, NY

NYU Winthrop Hospital

Mineola, NY

University of Rochester Medical Center
James P. Wilmot Cancer Center

Rochester, NY

SUNY Upstate Medical University
State University of New York

Syracuse, NY

Reading Hospital and Medical Center

Reading, PA

Prisma Health
Greenville Memorial Hospital

Greenville, SC

Prisma Health
Spartanburg

Spartanburg, SC

Baptist Cancer Center Memphis

Mempis, TN

University of Washington School of Medicine

Seattle, WA

West Virginia University

Morgantown, WV

Alabama
California
Colorado
Connecticut
Florida
Miami Cancer Institute
Baptist Health South Florida

Miami, FL

Cleveland Clinic Florida

Weston, FL

Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne North Office

Fort Wayne, IN

Blood and Marrow Transplantation
Franciscan Health

Indianapolis, IN

Iowa
Siouxland Hematology Oncology Associates

Sioux City, IA

Kansas
Kentucky
Norton Cancer Institute
St. Matthews Campus

Louisville, KY

Louisiana
Ochsner Medical Center

Jefferson, LA

Maryland
Massachusetts
Michigan
Cancer and Hematology Centers of Western Michigan (Grand Rapids)

Grand Rapids, MI

Mississippi
University of Mississippi Medical Center

Jackson, MS

Missouri
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
Northwell Health
Monter Cancer Center

Lake Success, NY

NYU Winthrop Hospital

Mineola, NY

University of Rochester Medical Center
James P. Wilmot Cancer Center

Rochester, NY

SUNY Upstate Medical University
State University of New York

Syracuse, NY

North Carolina
University of North Carolina
Lineberger Comprehensive Cancer Center

Chapel Hill, NC

Oregon
Pennsylvania
Reading Hospital and Medical Center

Reading, PA

South Carolina
Prisma Health
Greenville Memorial Hospital

Greenville, SC

Prisma Health
Spartanburg

Spartanburg, SC

Tennessee
Baptist Cancer Center Memphis

Mempis, TN

Texas
Utah
Washington
University of Washington School of Medicine

Seattle, WA

Cancer Care Northwest (Sherman)

Spokane, WA

West Virginia
West Virginia University

Morgantown, WV

Resources

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