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)

May 7, 2026 updated by: Janssen Research & Development, LLC

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X6
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec Universite Laval Hopital de l Enfant Jesus
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Birmingham
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Arizona Oncology Associates, PC - HAL
      • Goodyear, Arizona, United States, 85338
        • Cancer Treatment Center of America Phoenix
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego (UCSD) - The Rebecca and John Moores Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA David Geffen School of Medicine
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
      • Fort Collins, Colorado, United States, 80528
        • University of Colorado Health
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University Medical Center
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Cancer Center
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer and Blood Center LLC
    • Illinois
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists
      • Zion, Illinois, United States, 60099
        • Cancer Treatment Centers of America
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology and Hematology American Oncology Partners
      • Indianapolis, Indiana, United States, 46237-8601
        • Franciscan Health
    • Kansas
      • Westwood, Kansas, United States, 66160
        • University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Greenebaum Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion
      • Grand Rapids, Michigan, United States, 49503
        • Cancer And Hematology Centers of Western Michigan PC
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • HCA MidAmerica Division Inc Research Medical Center
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Summit Medical Group/MD Anderson Cancer Center
      • New Brunswick, New Jersey, United States, 08901-1914
        • Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ)
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology
      • Lake Success, New York, United States, 11042
        • Northwell Health
      • Mineola, New York, United States, 11501
        • NYU Winthrop
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • Syracuse, New York, United States, 13210
        • Suny Upstate Medical University
      • The Bronx, New York, United States, 10467
        • Montefiore Einstein Center for Cancer Care
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7305
        • University of North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute, Carolinas HealthCare System
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Charlotte
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Oncology Hematology Care
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97227
        • Northwest Cancer Specialists PC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-4215
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19111
        • Temple University Hospital Jeanes Campus
      • Pittsburgh, Pennsylvania, United States, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital/McGlinn Cancer Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29615-4816
        • Greenville Health System Cancer Institute
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Health Services
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology Chattanooga
      • Memphis, Tennessee, United States, 38120
        • Baptist Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology
    • Texas
      • Austin, Texas, United States, 78745
        • Texas Oncology-Central South
      • Dallas, Texas, United States, 75235
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Texas Oncology P A 1
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Mays Cancer Center (UT Health San Antonio)
      • Tyler, Texas, United States, 75702
        • Texas Oncology P A
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Healthcare System
      • Spokane, Washington, United States, 99216
        • Cancer Care Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must have newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT on the date 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
  • Must 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 slides (preferably 5, if available), 5 micrometer each, of non-decalcified bone marrow, or; (ii) Slides (preferably 5, if available), bone marrow aspirate smear; (iii) Please note, bone marrow core sections are not acceptable samples for analysis; (iv) In exceptional circumstances when index myeloma clone cannot be identified from the archived bone marrow sample, a post-transplant sample can be used to identify myeloma clone with permission from the sponsor
  • 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
  • Must not have progressed on multiple myeloma (MM) therapy at any time prior to screening
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daratumumab + Lenalidomide
Participants will receive 1800 milligram (mg) daratumumab by subcutaneous (SC) injection in combination with lenalidomide (orally) as maintenance therapy for a maximum of 36 cycles. Each cycle is of 28 days.
Drug: Daratumumab
Daratumumab 1800 mg will be administered by SC injection weekly during Cycles 1 and 2, every 2 weeks during Cycles 3 through 6, and every 4 weeks from Cycle 7 onward until confirmed progressive disease (PD), unacceptable toxicity, or until end of study treatment for a maximum of 36 cycles.
Other Names:
  • DARZALEX
Drug: Lenalidomide
Lenalidomide 10 mg will be administered orally from Day 1 to Day 28 (continuously) of each 28-day cycle until confirmed PD, unacceptable toxicity, or until end of study treatment for a maximum of 36 cycles. After 3 cycles of maintenance therapy, if well tolerated, the lenalidomide dose may be increased to 15 mg daily, at the discretion of the investigator.
Active Comparator: Lenalidomide
Participants will receive lenalidomide (orally) alone as maintenance therapy for a maximum of 36 cycles. Each cycle is of 28 days.
Drug: Lenalidomide
Lenalidomide 10 mg will be administered orally from Day 1 to Day 28 (continuously) of each 28-day cycle until confirmed PD, unacceptable toxicity, or until end of study treatment for a maximum of 36 cycles. After 3 cycles of maintenance therapy, if well tolerated, the lenalidomide dose may be increased to 15 mg daily, at the discretion of the investigator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Had Minimal Residual Disease (MRD) Conversion From Baseline to 12 Months After Start of Maintenance Treatment as Determined by Next Generation Sequencing (NGS)
Time Frame: From randomization up to 12 months
Percentage of participants who achieved MRD negative (MRD conversion) status from baseline to 12 months after maintenance treatment was defined as percentage of participants who were MRD positive at baseline (randomization) and achieved MRD negative status (at 10^-5) during the time period from randomization to 12 months plus 2 months window, but prior to progressive disease (PD) and subsequent anti-myeloma therapy.
From randomization up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival (PFS)
Time Frame: From randomization to either disease progression or death (up to 7.1 years)
From randomization to either disease progression or death (up to 7.1 years)
Percentage of Participants Who Achieved Overall MRD (at 10^-5) Negativity Conversion From Baseline to End of Study Treatment Period
Time Frame: From randomization up to 30 days after last dose of study treatment or disease progression or initiation of subsequent therapy, whichever occurs first (up to 3 years)
From randomization up to 30 days after last dose of study treatment or disease progression or initiation of subsequent therapy, whichever occurs first (up to 3 years)
Percentage of Participants Who Achieved Durable (Greater Than or Equal to [>=] 12 Months) MRD Negative Status (10^-5)
Time Frame: From randomization up to 30 days after last dose of study treatment or disease progression or initiation of subsequent therapy, whichever occurs first (up to 3 years)
From randomization up to 30 days after last dose of study treatment or disease progression or initiation of subsequent therapy, whichever occurs first (up to 3 years)
Response Rates by International Myeloma Working Group (IMWG) 2016 Criteria
Time Frame: From randomization up to 30 days after last dose of study treatment or disease progression or initiation of subsequent therapy, whichever occurs first (up to 3 years)
From randomization up to 30 days after last dose of study treatment or disease progression or initiation of subsequent therapy, whichever occurs first (up to 3 years)
Overall Survival (OS)
Time Frame: From randomization up to 7.1 years
From randomization up to 7.1 years
Duration of Complete Response (CR)
Time Frame: From date of initial documentation of CR or sCR up to first documented disease progression or death due to disease progression whichever occurs first (up to 7.1 years)
From date of initial documentation of CR or sCR up to first documented disease progression or death due to disease progression whichever occurs first (up to 7.1 years)
Health-related Quality of Life: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-C30 (EORTC QLQ-C30)
Time Frame: From baseline (Cycle 1 Day 1) up to 7.1 years
From baseline (Cycle 1 Day 1) up to 7.1 years
Health-related Quality of Life: Change From Baseline in European Quality of Life Five Dimensions Questionnaire-5-level (EQ-5D-5L)
Time Frame: From baseline (Cycle 1 Day 1) up to 7.1 years
From baseline (Cycle 1 Day 1) up to 7.1 years
Health-related Quality of Life: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Multiple Myeloma Module (EORTC QLQ-MY20)
Time Frame: From baseline (Cycle 1 Day 1) up to 7.1 years
From baseline (Cycle 1 Day 1) up to 7.1 years
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 7.1 years)
From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 7.1 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2019

Primary Completion (Actual)

April 4, 2024

Study Completion (Estimated)

May 29, 2026

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (Actual)

April 3, 2019

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108599
  • 54767414MMY3021 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Daratumumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe