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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
Sponsor: Celgene
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).
Official title: A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
79
Start Date
2023-10-16
Completion Date
2029-11-20
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
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
Locations (101)
Local Institution - 0131
Los Angeles, California, United States
Local Institution - 0126
Orange, California, United States
Local Institution - 0113
Sacramento, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
AdventHealth Orlando
Orlando, Florida, United States
Local Institution - 0121
Atlanta, Georgia, United States
Local Institution - 0104
Atlanta, Georgia, United States
Local Institution - 0151
Boston, Massachusetts, United States
Ascension Providence Hospital
Southfield, Michigan, United States
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Irving Medical Center
New York, New York, United States
Novant Health Cancer Institute - Elizabeth
Charlotte, North Carolina, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Local Institution - 0132
Philadelphia, Pennsylvania, United States
Local Institution - 0124
Austin, Texas, United States
Local Institution - 0109
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Local Institution - 0007
Camperdown, New South Wales, Australia
Local Institution - 0005
Brisbane, Queensland, Australia
Local Institution - 0004
Melbourne, Victoria, Australia
Local Institution - 0006
Melbourne, Victoria, Australia
Local Institution - 0008
Melbourne, Victoria, Australia
Local Institution - 0011
Murdoch, Western Australia, Australia
Local Institution - 0089
Salzburg, Austria
Local Institution - 0090
Vienna, Austria
Local Institution - 0083
Anderlecht, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0084
Brussels, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0144
Brussels, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0133
Edmonton, Alberta, Canada
Local Institution - 0001
Hamilton, Ontario, Canada
Local Institution - 0134
Montreal, Quebec, Canada
Local Institution - 0070
Odense, Region Syddanmark, Denmark
Local Institution - 0047
Pessac, Aquitaine, France
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône, France
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Pays de la Loire Region, France
Local Institution - 0046
Pierre-Bénite, Rhône, France
Henri Mondor Hospital
Créteil, Val-de-Marne, France
Local Institution - 0028
Villejuif, Val-de-Marne, France
Local Institution - 0029
Poitiers, Vienne, France
Local Institution - 0082
Paris, France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, France
Local Institution - 0031
Paris, Île-de-France Region, France
Local Institution - 0072
Heidelberg, Baden-Wurttemberg, Germany
Local Institution - 0078
Ulm, Baden-Wurttemberg, Germany
Local Institution - 0077
Nuremberg, Bavaria, Germany
Local Institution - 0073
Cologne, North Rhine-Westphalia, Germany
Local Institution - 0087
Leipzig, Saxony, Germany
Local Institution - 0079
Dresden, Germany
Local Institution - 0115
Essen, Germany
Local Institution - 0076
Hamburg, Germany
Local Institution - 0074
Würzburg, Germany
Local Institution - 0063
Pátrai, Achaḯa, Greece
Local Institution - 0061
Athens, Attikí, Greece
Local Institution - 0062
Chaïdári, Attikí, Greece
Local Institution - 0060
Thessaloniki, Thessaloníki, Greece
Local Institution - 0058
Petah Tikva, Central District, Israel
Local Institution - 0057
Ramat Gan, Central District, Israel
Local Institution - 0055
Beersheba, Southern District, Israel
Local Institution - 0088
Tel Aviv, Tell Abīb, Israel
Local Institution - 0056
Haifa, Israel
Local Institution - 0059
Jerusalem, Israel
Local Institution - 0064
Rozzano, Milano, Italy
Local Institution - 0065
Bologna, Italy
Local Institution - 0066
Roma, Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0085
Isehara, Kanagawa, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan
Chiba University Hospital
Chiba, Japan
Kyushu University Hospital
Fukuoka, Japan
Okayama University Hospital
Okayama, Japan
Local Institution - 0071
Shimotsuke, Japan
Local Institution - 0069
Oslo, Norway
Local Institution - 0027
Lublin, Lublin Voivodeship, Poland
Local Institution - 0095
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0023
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0022
Gliwice, Silesian Voivodeship, Poland
Local Institution - 0026
Gdansk, Poland
Local Institution - 0024
Poznan, Poland
Local Institution - 0091
Bucharest, Romania
Chonnam National University Hwasun Hospital
Hwasun, Jeonranamdo, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0038
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0043
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi, South Korea
Local Institution - 0020
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0017
L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0012
Pamplona, Navarre, Spain
Local Institution - 0021
Madrid, Spain
Local Institution - 0013
Salamanca, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Local Institution - 0093
Birmingham, England, United Kingdom
Local Institution - 0080
London, London, City of, United Kingdom
Local Institution - 0094
London, London, City of, United Kingdom