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).
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 79 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03901963 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen Research & Development, LLC |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
Principal Investigator Affiliation | Janssen Research & Development, LLC |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Canada, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
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.
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: - 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.
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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Alabama Birmingham
Birmingham, Alabama, 35294
Status
Recruiting
Address
Arizona Oncology Associates, PC - HAL
Glendale, Arizona, 85308
Status
Recruiting
Address
Cancer Treatment Center of America, Phoenix
Goodyear, Arizona, 85338
Status
Recruiting
Address
University of California San Diego (UCSD) - The Rebecca and John Moores Cancer Center
La Jolla, California, 92093
Status
Recruiting
Address
UCLA David Geffen School of Medicine
Los Angeles, California, 90095
Status
Recruiting
Address
University of California San Francisco
San Francisco, California, 94143
Status
Recruiting
Address
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Status
Recruiting
Address
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Status
Recruiting
Address
University of Colorado Health
Fort Collins, Colorado, 80528
Status
Recruiting
Address
Yale University Medical Center
New Haven, Connecticut, 06510
Status
Recruiting
Address
MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
Status
Recruiting
Address
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
Status
Recruiting
Address
University of Miami/Sylvester Cancer Center
Miami, Florida, 33136
Status
Recruiting
Address
Miami Cancer Institute
Miami, Florida, 33176
Status
Recruiting
Address
Moffitt Cancer Center
Tampa, Florida, 33612
Status
Recruiting
Address
Cleveland Clinic Florida
Weston, Florida, 33331
Status
Recruiting
Address
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Status
Recruiting
Address
Illinois Cancer Specialists
Niles, Illinois, 60714
Status
Recruiting
Address
Cancer Treatment Centers of America
Zion, Illinois, 60099
Status
Recruiting
Address
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46804
Status
Recruiting
Address
Franciscan Health
Indianapolis, Indiana, 46237-8601
Status
Completed
Address
University of Kansas Cancer Center
Westwood, Kansas, 66160
Status
Completed
Address
Norton Cancer Institute
Louisville, Kentucky, 40207
Status
Recruiting
Address
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Status
Recruiting
Address
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201
Status
Recruiting
Address
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Status
Recruiting
Address
Henry Ford Cancer Institute
Detroit, Michigan, 48202-2608
Status
Recruiting
Address
Cancer & Hematology Centers of Western Michigan, PC
Grand Rapids, Michigan, 49503
Status
Recruiting
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Recruiting
Address
Sarah Cannon Cancer Institute
Kansas City, Missouri, 64132
Status
Completed
Address
Summit Medical Group/MD Anderson Cancer Center
Florham Park, New Jersey, 07932
Status
Recruiting
Address
Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ)
New Brunswick, New Jersey, 08901-1914
Status
Completed
Address
New York Oncology Hematology
Albany, New York, 12206
Status
Recruiting
Address
Montefiore Einstein Center for Cancer Care
Bronx, New York, 10467
Status
Recruiting
Address
Northwell Health
Lake Success, New York, 11042
Status
Recruiting
Address
NYU Winthrop
Mineola, New York, 11501
Status
Completed
Address
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Status
Completed
Address
Columbia University Medical Center
New York, New York, 10032
Status
Recruiting
Address
SUNY Upstate Medical University
Syracuse, New York, 13210
Status
Recruiting
Address
University of North Carolina
Chapel Hill, North Carolina, 27599-7305
Status
Recruiting
Address
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina, 28204
Status
Recruiting
Address
Novant Health
Charlotte, North Carolina, 28204
Status
Recruiting
Address
Novant Oncology Research Institute
Winston-Salem, North Carolina, 27103
Status
Recruiting
Address
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
Status
Recruiting
Address
Oncology Hematology Care
Cincinnati, Ohio, 45236
Status
Completed
Address
Northwest Cancer Specialists PC
Portland, Oregon, 97227
Status
Recruiting
Address
Oregon Health & Science University
Portland, Oregon, 97239
Status
Recruiting
Address
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-4215
Status
Recruiting
Address
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Status
Recruiting
Address
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Status
Recruiting
Address
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15323
Status
Recruiting
Address
Reading Hospital/McGlinn Cancer Institute
West Reading, Pennsylvania, 19611
Status
Recruiting
Address
Greenville Health System Cancer Institute
Greenville, South Carolina, 29615-4816
Status
Recruiting
Address
Spartanburg Regional Health Services
Spartanburg, South Carolina, 29303
Status
Completed
Address
Tennessee Oncology
Chattanooga, Tennessee, 37404
Status
Recruiting
Address
Baptist Cancer Center
Memphis, Tennessee, 38120
Status
Recruiting
Address
Tennessee Oncology
Nashville, Tennessee, 37203
Status
Recruiting
Address
Texas Oncology P.A.
Austin, Texas, 78705
Status
Recruiting
Address
UT Southwestern Medical Center
Dallas, Texas, 75235-9179
Status
Recruiting
Address
Texas Oncology P.A.
Dallas, Texas, 75246
Status
Recruiting
Address
MD Anderson Cancer Center
Houston, Texas, 77030
Status
Recruiting
Address
Mays Cancer Center (UT Health San Antonio)
San Antonio, Texas, 78229
Status
Recruiting
Address
Texas Oncology P.A.
Tyler, Texas, 75702
Status
Recruiting
Address
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Status
Recruiting
Address
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic
Charlottesville, Virginia, 22903
Status
Recruiting
Address
Virginia Cancer Specialists
Gainesville, Virginia, 20155
Status
Recruiting
Address
Virginia Oncology Associates
Norfolk, Virginia, 23502
Status
Completed
Address
VA Puget Sound Healthcare System
Seattle, Washington, 98108
Status
Recruiting
Address
University of Washington
Seattle, Washington, 98109
Status
Completed
Address
Cancer Care Northwest
Spokane, Washington, 99216
Status
Recruiting
Address
Princess Margaret Hospital
Toronto, Ontario, M5G 1X6
Status
Recruiting
Address
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Status
Recruiting
Address
CHU de Québec-Université Laval-Hôpital de l'Enfant-Jésus
Quebec, , G1R 2J6