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NCT03652064 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
A Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 395
- Enrollment target
- 20
- Study locations
NCT03652064: Active Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
NCT03652064 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 395 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03652064, 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
- 395 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.
Primary Outcome
Overall MRD negativity rate was defined as the percentage of participants who achieved complete response (CR) or better response and had MRD negative status (at 10\^5) by bone marrow biopsy or aspirate after randomization but prior to progressive disease (PD), subsequent anti-myeloma therapy, or both. CR or better rate was defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent anti-myeloma therapy in accordance with the International Myelo
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Daratumumab
- DRUG Bortezomib
Study Locations (20)
Massachusetts
- Tufts Medical Center - Boston
- Boston University Medical Center - Boston
New York
- Roswell Park Cancer Institute - Buffalo
- NYU Winthrop - Mineola
California
- Innovative Clinical Research Inc - Cerritos
Florida
- Baptist MD Anderson - Jacksonville
Indiana
- Fort Wayne Medical Oncology and Hematology, Inc. - Fort Wayne
Kentucky
- Norton Healthcare - Louisville
Michigan
- Cancer And Hematology Centers of Western Michigan PC - Grand Rapids
Missouri
- Saint Lukes Hospital Saint Lukes Cancer Specialists - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2018-11-06 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
What the registry record for NCT03652064 still lists
NCT03652064 is an interventional study that assigns participants to a tested intervention. The registered 395 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 (28% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Dexamethasone is the first listed.
NCT03652064 names 20 study sites across 18 states, led by Massachusetts, New York, California.
Frequently Asked Questions
What is clinical trial NCT03652064 about?
NCT03652064 is a clinical study titled "A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy". The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.
What is the current status of trial NCT03652064?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 395 participants. The study started on 2018-11-06. Estimated completion is 2026-03-31.
What conditions does trial NCT03652064 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT03652064?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT03652064?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03652064 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Kentucky, Massachusetts. 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 NCT03652064's enrollment target sits among peer trials
395 59th of 438 higher than 380 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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