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NCT04923893 · ClinicalTrials.gov registry record · Phase 3
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT 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
- 743
- Enrollment target
- 20
- Study locations
NCT04923893: Active Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
NCT04923893 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 743 participants, above the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (36% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04923893, 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
- 743 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).
Primary Outcome
Progression-free survival is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Cilta-cel
- DRUG Bortezomib
Study Locations (20)
New York
- Columbia University Medical Center - New York
- Memorial Sloan-Kettering Cancer Center - New York
- New York Presbyterian-Weill Cornell Medical College - New York
Florida
- University of Miami Health System - Miami
- AdventHealth Cancer Institute - Orlando
Kentucky
- University of Kentucky - Lexington
- Norton Cancer Institute - Louisville
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
- Henry Ford Cancer Institute - Detroit
Pennsylvania
- Thomas Jefferson University - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
California
- UCSF - San Francisco
Connecticut
- Yale Cancer Center - New Haven
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 743 participants |
| Start Date | 2021-08-19 |
| Est. Completion | 2036-09-22 |
| Phase | Phase 3 |
What the registry record for NCT04923893 still lists
NCT04923893 is an interventional study that assigns participants to a tested intervention. The registered 743 participants enrollment target is mid-sized for trials with a published cap, above the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (36% higher).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04923893 names 20 study sites across 14 states, led by New York, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04923893 about?
NCT04923893 is a clinical study titled "A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy". The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple...
What is the current status of trial NCT04923893?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 743 participants. The study started on 2021-08-19. Estimated completion is 2036-09-22.
What conditions does trial NCT04923893 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT04923893?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Cilta-cel (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT04923893?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04923893 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Iowa, Kentucky. 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 NCT04923893's enrollment target sits among peer trials
743 31st of 438 higher than 408 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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