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NCT06045806 · ClinicalTrials.gov registry record · Phase 3

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

A Phase 3 study of Multiple Myeloma, sponsored by Celgene.

Active
Registry status
Phase 3
Development phase
79
Enrollment target
20
Study locations

NCT06045806: Active Phase 3 study of Multiple Myeloma, sponsored by Celgene.

NCT06045806 is a Phase 3 study of Multiple Myeloma that is active but no longer recruiting, run by Celgene. The registered enrollment target is 79 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06045806, a Phase 3 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Celgene.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
79 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

Conditions Studied

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Lenalidomide
  • BIOLOGICAL idecabtagene vicleucel

Study Locations (20)

California

  • Local Institution - 0131 - Los Angeles
  • Local Institution - 0126 - Orange
  • Local Institution - 0113 - Sacramento

Texas

  • Local Institution - 0124 - Austin
  • Local Institution - 0109 - Houston
  • University of Texas MD Anderson Cancer Center - Houston

Georgia

  • Local Institution - 0121 - Atlanta
  • Local Institution - 0104 - Atlanta

Missouri

  • Washington University School of Medicine - St Louis
  • Washington University School of Medicine - St Louis

Colorado

  • Colorado Blood Cancer Institute - Denver

Connecticut

  • Yale University School of Medicine - New Haven

Florida

  • AdventHealth Orlando - Orlando

Massachusetts

  • Local Institution - 0151 - Boston

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2023-10-16
Est. Completion 2029-11-20
Phase Phase 3

Sponsor

Celgene

308 total trials

What the Registry Record Tells You About NCT06045806

The ClinicalTrials.gov registry entry for NCT06045806 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (86% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT06045806 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Texas, Georgia.

Frequently Asked Questions

What is clinical trial NCT06045806 about?

NCT06045806 is a clinical study titled "A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation". The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transpla...

What is the current status of trial NCT06045806?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 79 participants. The study started on 2023-10-16. Estimated completion is 2029-11-20.

What conditions does trial NCT06045806 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT06045806?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Lenalidomide (DRUG), idecabtagene vicleucel (BIOLOGICAL).

Who is sponsoring clinical trial NCT06045806?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06045806 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. 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

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, the data changelog, or report a data error.