Multiple MyelomaPhase 3AURIGANCT03901963
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
A Phase 3 study testing Daratumumab and Lenalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 73 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Daratumumab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 73 sitesin 2 countries
- Study dates
- 26 Apr 2019to 4 May 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
73 sites in 2 countries.
73 sites in 2 countries
United States70 sites
New York Oncology Hematology
Albany, New York, 12206
University Cancer And Blood Center LLC
Athens, Georgia, 30607
Texas Oncology-Central South
Austin, Texas, 78745
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
University of Alabama Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of North Carolina
Chapel Hill, North Carolina, 27599-7305
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina, 28204
Novant Health Charlotte
Charlotte, North Carolina, 28204
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic
Charlottesville, Virginia, 22903
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404
Oncology Hematology Care
Cincinnati, Ohio, 45236
UT Southwestern Medical Center
Dallas, Texas, 75235
Texas Oncology P A 1
Dallas, Texas, 75246
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion
Detroit, Michigan, 48202
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Summit Medical Group/MD Anderson Cancer Center
Florham Park, New Jersey, 07932
University of Colorado Health
Fort Collins, Colorado, 80528
Fort Wayne Medical Oncology and Hematology American Oncology Partners
Fort Wayne, Indiana, 46804
Arizona Oncology Associates, PC - HAL
Glendale, Arizona, 85308
Cancer Treatment Center of America Phoenix
Goodyear, Arizona, 85338
Cancer And Hematology Centers of Western Michigan PC
Grand Rapids, Michigan, 49503
Greenville Health System Cancer Institute
Greenville, South Carolina, 29615-4816
MD Anderson Cancer Center
Houston, Texas, 77030
Franciscan Health
Indianapolis, Indiana, 46237-8601
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
HCA MidAmerica Division Inc Research Medical Center
Kansas City, Missouri, 64132
University of California San Diego (UCSD) - The Rebecca and John Moores Cancer Center
La Jolla, California, 92093
Northwell Health
Lake Success, New York, 11042
UCLA David Geffen School of Medicine
Los Angeles, California, 90095
Norton Cancer Institute
Louisville, Kentucky, 40207
Baptist Cancer Center
Memphis, Tennessee, 38120
University of Miami Sylvester Cancer Center
Miami, Florida, 33136
Miami Cancer Institute
Miami, Florida, 33176
NYU Winthrop
Mineola, New York, 11501
Tennessee Oncology
Nashville, Tennessee, 37203
Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ)
New Brunswick, New Jersey, 08901-1914
Yale University Medical Center
New Haven, Connecticut, 06510
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Illinois Cancer Specialists
Niles, Illinois, 60714
Virginia Oncology Associates
Norfolk, Virginia, 23502
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-4215
Temple University Hospital Jeanes Campus
Philadelphia, Pennsylvania, 19111
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Northwest Cancer Specialists PC
Portland, Oregon, 97227
Oregon Health And Science University
Portland, Oregon, 97239
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Mays Cancer Center (UT Health San Antonio)
San Antonio, Texas, 78229
University of California San Francisco
San Francisco, California, 94143
VA Puget Sound Healthcare System
Seattle, Washington, 98108
University of Washington
Seattle, Washington, 98109
Spartanburg Regional Health Services
Spartanburg, South Carolina, 29303
Cancer Care Northwest
Spokane, Washington, 99216
SUNY Upstate Medical University
Syracuse, New York, 13210
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10467
Texas Oncology P A
Tyler, Texas, 75702
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Reading Hospital/McGlinn Cancer Institute
West Reading, Pennsylvania, 19611
Cleveland Clinic Florida
Weston, Florida, 33331
University of Kansas Cancer Center
Westwood, Kansas, 66160
Novant Health
Winston-Salem, North Carolina, 27103
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
Cancer Treatment Centers of America
Zion, Illinois, 60099
Canada3 sites
McGill University Health Centre
Montreal, Quebec, H4A 3J1
CHU de Quebec Universite Laval Hopital de l Enfant Jesus
Québec, Quebec, G1R 2J6
Princess Margaret Hospital
Toronto, Ontario, M5G 1X6
About this study
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
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).
- Conditions
- Multiple Myeloma
- Being tested
- Daratumumab, Lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Also called DARZALEX
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.
LenalidomideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Daratumumab + Lenalidomide | Experimental | 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. Receives: Drug: Daratumumab; Drug: Lenalidomide |
| Lenalidomide | Active comparator | Participants will receive lenalidomide (orally) alone as maintenance therapy for a maximum of 36 cycles. Each cycle is of 28 days. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: From randomization up to 12 months
Secondary outcomes (10)
Progression-free Survival (PFS)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: From randomization up to 7.1 years
Duration of Complete Response (CR)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From baseline (Cycle 1 Day 1) up to 7.1 years
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start26 Apr 2019
- Primary completion4 Apr 2024
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901963
- Sponsor's protocol ID
- CR108599
- Other IDs
- 54767414MMY3021
- Acronym
- AURIGA
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2019
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Badros A, Foster L, Anderson LD Jr, Chaulagain CP, Pettijohn E, Cowan AJ, Costello C, Larson S, Sborov DW, Shain KH, Silbermann R, Shah N, Chung A, Krevvata M, Pei H, Patel S, Khare V, Cortoos A, Carson R, Lin TS, Voorhees P. Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: the AURIGA study. Blood. 2025 Jan 16;145(3):300-310. doi: 10.1182/blood.2024025746.
PubMed 39331724Swan D, Henderson R, McEllistrim C, Naicker SD, Quinn J, Cahill MR, Mykytiv V, Lenihan E, Mulvaney E, Nolan M, Parker I, Natoni A, Lynch K, Ryan AE, Szegezdi E, Krawczyk J, Murphy P, O'Dwyer M. CyBorD-DARA in Newly Diagnosed Transplant-Eligible Multiple Myeloma: Results from the 16-BCNI-001/CTRIAL-IE 16-02 Study Show High Rates of MRD Negativity at End of Treatment. Clin Lymphoma Myeloma Leuk. 2022 Nov;22(11):847-852. doi: 10.1016/j.clml.2022.07.011. Epub 2022 Jul 21.
PubMed 35985959