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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 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.

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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).

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

FieldValue
Enrollment Target 743 participants
Start Date 2021-08-19
Est. Completion 2036-09-22
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT04923893

The ClinicalTrials.gov registry entry for NCT04923893 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 743 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (36% higher). 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 5 interventions - of which Cyclophosphamide is the first listed.

NCT04923893 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.