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
Condition(s) studied
Investigational drug(s) / intervention(s)
idecabtagene vicleucel: Specified dose on specified days
Lenalidomide: Specified dose on specified days
Fludarabine: Specified dose on specified days
Cyclophosphamide: Specified dose on specified days
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).
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — Up to approximately 50 months after the first participant is randomized
PFS as assessed by Independent Review Committee (IRC)
Trial sites (101)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0131 | Los Angeles | California | |
| Local Institution - 0126 | Orange | California | |
| Local Institution - 0113 | Sacramento | California | |
| Colorado Blood Cancer Institute | Denver | Colorado | |
| Yale University School of Medicine | New Haven | Connecticut | |
| AdventHealth Orlando | Orlando | Florida | |
| Local Institution - 0121 | Atlanta | Georgia | |
| Local Institution - 0104 | Atlanta | Georgia | |
| Local Institution - 0151 | Boston | Massachusetts | |
| Ascension Providence Hospital | Southfield | Michigan | |
| M Health Fairview Clinics and Surgery Center | Minneapolis | Minnesota | |
| Washington University School of Medicine | St Louis | Missouri | |
| Washington University School of Medicine | St Louis | Missouri | |
| Columbia University Irving Medical Center | New York | New York | |
| Novant Health Cancer Institute - Elizabeth | Charlotte | North Carolina | |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | |
| Local Institution - 0132 | Philadelphia | Pennsylvania | |
| Local Institution - 0124 | Austin | Texas | |
| Local Institution - 0109 | Houston | Texas | |
| University of Texas MD Anderson Cancer Center | Houston | Texas | |
| Local Institution - 0007 | Camperdown | New South Wales | |
| Local Institution - 0005 | Brisbane | Queensland | |
| Local Institution - 0004 | Melbourne | Victoria | |
| Local Institution - 0006 | Melbourne | Victoria | |
| Local Institution - 0008 | Melbourne | Victoria | |
| Local Institution - 0011 | Murdoch | Western Australia | |
| Local Institution - 0089 | Salzburg | Austria | |
| Local Institution - 0090 | Vienna | Austria | |
| Local Institution - 0083 | Anderlecht | Bruxelles-Capitale, Région de | |
| Local Institution - 0084 | Brussels | Bruxelles-Capitale, Région de | |
| Local Institution - 0144 | Brussels | Bruxelles-Capitale, Région de | |
| Local Institution - 0133 | Edmonton | Alberta | |
| Local Institution - 0001 | Hamilton | Ontario | |
| Local Institution - 0134 | Montreal | Quebec | |
| Local Institution - 0070 | Odense | Region Syddanmark | |
| Local Institution - 0047 | Pessac | Aquitaine | |
| Institut Paoli-Calmettes | Marseille | Bouches-du-Rhône | |
| Hopital Claude Huriez - CHU de Lille | Lille | Nord | |
| Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu | Nantes | Pays de la Loire Region | |
| Local Institution - 0046 | Pierre-Bénite | Rhône |
+ 61 more sites — see the full list on the official registry below.
On this site
📄 Revlimid (lenalidomide) drug profile →More Celgene trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06045806 on ClinicalTrials.gov ↗ ← All trials in South Korea