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NCT04181827 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma
A Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 419
- Enrollment target
- 20
- Study locations
NCT04181827: Active Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
NCT04181827 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 419 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (23% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04181827, 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
- 419 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
Primary Outcome
PFS: defined as time from date of randomization to date of first documented progressed disease (PD) as per International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams per deciliter \[g/dL\] and \>=200 milligrams \[mg\] per 24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference betwe
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Daratumumab
- DRUG Pomalidomide
- DRUG Cilta-cel
- DRUG Bortezomib
Study Locations (20)
New York
- Memorial Sloan-Kettering Cancer Center - New York
- University of Rochester Medical Center - Rochester
Wisconsin
- Wisconsin Institutes for Medical Research - Madison
- Medical College Of Wisconsin - Milwaukee
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic Cancer Center-Scottsdale - Phoenix
California
- Stanford University Medical Center - Stanford
Colorado
- Colorado Blood Cancer Institute - Denver
Connecticut
- Yale New Haven Hospital - New Haven
Florida
- University Of Miami Leonard M Mille School Of Medicine SCCC - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 419 participants |
| Start Date | 2020-06-12 |
| Est. Completion | 2029-04-09 |
| Phase | Phase 3 |
What the registry record for NCT04181827 still lists
NCT04181827 is an interventional study that assigns participants to a tested intervention. The registered 419 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 (23% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.
NCT04181827 names 20 study sites across 18 states, led by New York, Wisconsin, Alabama.
Frequently Asked Questions
What is clinical trial NCT04181827 about?
NCT04181827 is a clinical study titled "A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma". The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
What is the current status of trial NCT04181827?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 419 participants. The study started on 2020-06-12. Estimated completion is 2029-04-09.
What conditions does trial NCT04181827 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT04181827?
The interventions under investigation include: Dexamethasone (DRUG), Daratumumab (DRUG), Pomalidomide (DRUG), Cilta-cel (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT04181827?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04181827 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 NCT04181827's enrollment target sits among peer trials
419 57th of 438 higher than 382 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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