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NCT03901963 · ClinicalTrials.gov registry record · Phase 3
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 of Multiple Myeloma, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT03901963 is a Phase 3 study of Multiple Myeloma that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 200 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT03901963, a Phase 3 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study 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 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 Studied
Interventions
- DRUG Lenalidomide
- DRUG Daratumumab
Study Locations (20)
Florida
- Cancer Specialists of North Florida - Jacksonville
- University of Miami Sylvester Cancer Center - Miami
- Miami Cancer Institute - Miami
- Moffitt Cancer Center - Tampa
- Cleveland Clinic Florida - Weston
California
- University of California San Diego (UCSD) - The Rebecca and John Moores Cancer Center - La Jolla
- UCLA David Geffen School of Medicine - Los Angeles
- University of California San Francisco - San Francisco
Colorado
- Colorado Blood Cancer Institute - Denver
- Rocky Mountain Cancer Centers - Denver
- University of Colorado Health - Fort Collins
Arizona
- Arizona Oncology Associates, PC - HAL - Glendale
- Cancer Treatment Center of America Phoenix - Goodyear
Illinois
- Illinois Cancer Specialists - Niles
- Cancer Treatment Centers of America - Zion
Alabama
- University of Alabama Birmingham - Birmingham
Connecticut
- Yale University Medical Center - New Haven
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-04-26 |
| Est. Completion | 2026-05-29 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03901963
The ClinicalTrials.gov registry entry for NCT03901963 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (63% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Lenalidomide is the first listed.
NCT03901963 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT03901963 about?
NCT03901963 is a clinical study titled "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". 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 particip...
What is the current status of trial NCT03901963?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2019-04-26. Estimated completion is 2026-05-29.
What conditions does trial NCT03901963 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT03901963?
The interventions under investigation include: Lenalidomide (DRUG), Daratumumab (DRUG).
Who is sponsoring clinical trial NCT03901963?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03901963 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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