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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.
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).
Primary Outcome
PFS as assessed by Independent Review Committee (IRC)
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
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2023-10-16 |
| Est. Completion | 2029-11-20 |
| Phase | Phase 3 |
What the registry record for NCT06045806 still lists
NCT06045806 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (86% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
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Where NCT06045806's enrollment target sits among peer trials
79 202nd of 438 higher than 236 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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