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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: Active Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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.
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 |
What the registry record for NCT03901963 still lists
NCT03901963 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (63% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03901963's enrollment target sits among peer trials
200 110th of 438 higher than 324 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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