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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03901963

Public ClinicalTrials.gov record NCT03901963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 29, 2026, 11:48 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03901963
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
200 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 79 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 25, 2019
Primary completion
Apr 3, 2024
Completion
May 3, 2026
Last update posted
Jun 22, 2026

2019 – 2026

United States locations

U.S. sites
70
U.S. states
30
U.S. cities
60
Facility City State ZIP Site status
University of Alabama Birmingham Birmingham Alabama 35294 —
Arizona Oncology Associates, PC - HAL Glendale Arizona 85308 —
Cancer Treatment Center of America Phoenix Goodyear Arizona 85338 —
University of California San Diego (UCSD) - The Rebecca and John Moores Cancer Center La Jolla California 92093 —
UCLA David Geffen School of Medicine Los Angeles California 90095 —
University of California San Francisco San Francisco California 94143 —
Colorado Blood Cancer Institute Denver Colorado 80218 —
Rocky Mountain Cancer Centers Denver Colorado 80218 —
University of Colorado Health Fort Collins Colorado 80528 —
Yale University Medical Center New Haven Connecticut 06510 —
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007 —
Cancer Specialists of North Florida Jacksonville Florida 32256 —
University of Miami Sylvester Cancer Center Miami Florida 33136 —
Miami Cancer Institute Miami Florida 33176 —
Moffitt Cancer Center Tampa Florida 33612 —
Cleveland Clinic Florida Weston Florida 33331 —
University Cancer And Blood Center LLC Athens Georgia 30607 —
Illinois Cancer Specialists Niles Illinois 60714 —
Cancer Treatment Centers of America Zion Illinois 60099 —
Fort Wayne Medical Oncology and Hematology American Oncology Partners Fort Wayne Indiana 46804 —
Franciscan Health Indianapolis Indiana 46237-8601 —
University of Kansas Cancer Center Westwood Kansas 66160 —
Norton Cancer Institute Louisville Kentucky 40207 —
Ochsner Clinic Foundation New Orleans Louisiana 70121 —
University of Maryland Greenebaum Cancer Center Baltimore Maryland 21201 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion Detroit Michigan 48202 —
Cancer And Hematology Centers of Western Michigan PC Grand Rapids Michigan 49503 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
HCA MidAmerica Division Inc Research Medical Center Kansas City Missouri 64132 —
Summit Medical Group/MD Anderson Cancer Center Florham Park New Jersey 07932 —
Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ) New Brunswick New Jersey 08901-1914 —
New York Oncology Hematology Albany New York 12206 —
Northwell Health Lake Success New York 11042 —
NYU Winthrop Mineola New York 11501 —
Icahn School of Medicine at Mount Sinai New York New York 10029 —
Columbia University Medical Center New York New York 10032 —
SUNY Upstate Medical University Syracuse New York 13210 —
Montefiore Einstein Center for Cancer Care The Bronx New York 10467 —
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 —
Novant Health Winston-Salem North Carolina 27103 —
Wake Forest Health Sciences Winston-Salem North Carolina 27157 —
Oncology Hematology Care Cincinnati Ohio 45236 —
Northwest Cancer Specialists PC Portland Oregon 97227 —
Oregon Health And Science University Portland Oregon 97239 —
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 —
Reading Hospital/McGlinn Cancer Institute West Reading Pennsylvania 19611 —
Greenville Health System Cancer Institute Greenville South Carolina 29615-4816 —
Spartanburg Regional Health Services Spartanburg South Carolina 29303 —
Tennessee Oncology Chattanooga Chattanooga Tennessee 37404 —
Baptist Cancer Center Memphis Tennessee 38120 —
Tennessee Oncology Nashville Tennessee 37203 —
Texas Oncology-Central South Austin Texas 78745 —
UT Southwestern Medical Center Dallas Texas 75235 —
Texas Oncology P A 1 Dallas Texas 75246 —
MD Anderson Cancer Center Houston Texas 77030 —
Mays Cancer Center (UT Health San Antonio) San Antonio Texas 78229 —
Texas Oncology P A Tyler Texas 75702 —
Huntsman Cancer Institute Salt Lake City Utah 84112 —
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic Charlottesville Virginia 22903 —
Virginia Cancer Specialists Fairfax Virginia 22031 —
Virginia Oncology Associates Norfolk Virginia 23502 —
VA Puget Sound Healthcare System Seattle Washington 98108 —
University of Washington Seattle Washington 98109 —
Cancer Care Northwest Spokane Washington 99216 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03901963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 22, 2026 · Synced Sep 29, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03901963 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →