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
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT06045806
- Lead Sponsor
- Celgene
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 618
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A idecabtagene vicleucel - Arm A Lenalidomide - Arm A Cyclophosphamide - Arm A Fludarabine - Arm B Lenalidomide -
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Up to approximately 50 months after the first participant is randomized PFS as assessed by Independent Review Committee (IRC)
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 60 months after the last participant is randomized Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months From randomization up to 60 months from randomization Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR) From randomization up to 15 months from randomization Event-Free Survival (EFS) Up to approximately 60 months after the last participant is randomized Duration of Response (DOR) Up to approximately 60 months after the last participant is randomized Percentage of Participants with Complete Response (CR) Up to approximately 60 months after the last participant is randomized CR as assessed by IRC
Time to Progression (TTP) Up to approximately 60 months after the last participant is randomized Progression as assessed by IRC
Progression post-next line of treatment (PFS2) Up to approximately 60 months after the last participant is randomized Time to Next Treatment (TTNT) Up to approximately 60 months after the last participant is randomized Number of Participants Experiencing Adverse Events (AEs) Up to approximately 60 months after the last participant is randomized Number of Participants Experiencing Adverse Events of Special Interest (AESI) Up to approximately 60 months after the last participant is randomized Maximum Observed Plasma Concentration (Cmax) Up to approximately 60 months after the last participant is randomized Time of Maximum Observed Plasma Concentration (Tmax) Up to approximately 60 months after the last participant is randomized Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D]) Up to 28 days post infusion Time of Last Measurable Observed Plasma Concentration (Tlast) Up to approximately 60 months after the last participant is randomized Time-to-Definitive Deterioration Up to approximately 50 months after the first participant is randomized Time-to-definitive deterioration based on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 global health status/quality of life subscale
Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales Up to approximately 50 months after the first participant is randomized The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 will be assessed:
* Global health status/quality of life
* Physical Functioning
* Fatigue
* PainMean Change from Baseline in EORTC QLQ-MY20 Selected Subscales Up to approximately 50 months after the first participant is randomized The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-MY20 will be assessed:
* Disease symptoms
* Side-effects of treatment
Trial Locations
- Locations (100)
Local Institution - 0082
🇫🇷Paris, France
Local Institution - 0061
🇬🇷Athens, Attikí, Greece
Local Institution - 0062
🇬🇷Chaidari, Attikí, Greece
Local Institution - 0060
🇬🇷Thessaloniki, Thessaloníki, Greece
Local Institution - 0055
🇮🇱Be'er Sheva, HaDarom, Israel
Local Institution - 0058
🇮🇱Petah-Tikva, HaMerkaz, Israel
Local Institution - 0057
🇮🇱Ramat Gan, HaMerkaz, 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, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Medical University Hospital
🇯🇵Nishinomiya, Hyogo, Japan
Local Institution - 0038
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Local Institution - 0043
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Local Institution - 0069
🇳🇴Oslo, Norway
Local Institution - 0027
🇵🇱Lublin, Lubelskie, Poland
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
🇺🇸Saint 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
🇦🇹Wien, 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, 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, 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
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
🇫🇷Toulouse, France
Local Institution - 0031
🇫🇷Paris, Île-de-France, France
Local Institution - 0072
🇩🇪Heidelberg, Baden-Württemberg, Germany
Local Institution - 0078
🇩🇪Ulm, Baden-Württemberg, Germany
Local Institution - 0077
🇩🇪Nuremberg, Bayern, Germany
Local Institution - 0073
🇩🇪Köln, Nordrhein-Westfalen, Germany
Local Institution - 0087
🇩🇪Leipzig, Sachsen, Germany
Local Institution - 0079
🇩🇪Dresden, Germany
Local Institution - 0115
🇩🇪Essen, Germany
Local Institution - 0076
🇩🇪Hamburg, Germany
Local Institution - 0074
🇩🇪Wuerzburg, Germany
Local Institution - 0063
🇬🇷Patras, Achaḯa, Greece
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, 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
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeonranamdo, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Local Institution - 0095
🇵🇱Warsaw, Mazowieckie, Poland
Local Institution - 0023
🇵🇱Warsaw, Mazowieckie, Poland
Local Institution - 0026
🇵🇱Gdańsk, Poland
Local Institution - 0024
🇵🇱Poznań, Poland
Local Institution - 0022
🇵🇱Gliwice, Śląskie, Poland
Local Institution - 0091
🇷🇴Bucharest, Romania
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, Navarra, Spain
Local Institution - 0021
🇪🇸Madrid, Spain
Local Institution - 0013
🇪🇸Salamanca, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸València, 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