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).
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Inclusion Criteria.
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06045806 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Celgene |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bristol-Myers Squibb |
Principal Investigator Affiliation | Bristol-Myers Squibb |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Norway, Poland, Romania, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
Study Website: | View Trial Website |
Experimental: Arm A
Active Comparator: Arm B
Biological: - idecabtagene vicleucel
Specified dose on specified days
Drug: - Lenalidomide
Specified dose on specified days
Drug: - Fludarabine
Specified dose on specified days
Drug: - Cyclophosphamide
Specified dose on specified days
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Not yet recruiting
Address
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Status
Not yet recruiting
Address
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, 85259
Status
Not yet recruiting
Address
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
Los Angeles, California, 90095
Status
Not yet recruiting
Address
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
Status
Not yet recruiting
Address
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817
Status
Recruiting
Address
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Status
Not yet recruiting
Address
Yale University School of Medicine
New Haven, Connecticut, 06510
Status
Not yet recruiting
Address
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Status
Not yet recruiting
Address
AdventHealth Orlando
Orlando, Florida, 32804
Status
Not yet recruiting
Address
Moffitt Cancer Center
Tampa, Florida, 33612
Status
Not yet recruiting
Address
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Status
Not yet recruiting
Address
Northside Hospital
Atlanta, Georgia, 30342
Status
Not yet recruiting
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
Status
Withdrawn
Address
Boston Medical Center
Boston, Massachusetts, 02118
Status
Not yet recruiting
Address
Local Institution - 0123
Ann Arbor, Michigan, 48109
Status
Not yet recruiting
Address
Ascension Providence Hospital
Southfield, Michigan, 48075
Status
Not yet recruiting
Address
Local Institution - 0119
Minneapolis, Minnesota, 55455
Status
Not yet recruiting
Address
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
Status
Not yet recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Not yet recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Not yet recruiting
Address
Columbia University Irving Medical Center
New York, New York, 10032
Status
Not yet recruiting
Address
Novant Health Cancer Institute - Elizabeth
Charlotte, North Carolina, 28204
Status
Withdrawn
Address
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Status
Not yet recruiting
Address
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Status
Not yet recruiting
Address
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Status
Recruiting
Address
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
St. David's South Austin Medical Center
Austin, Texas, 78704
Status
Not yet recruiting
Address
UT Southwestern Medical Center
Dallas, Texas, 75390-88520
Status
Not yet recruiting
Address
Houston Methodist Hospital
Houston, Texas, 77030
Status
Not yet recruiting
Address
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Status
Not yet recruiting
Address
Local Institution - 0136
Richmond, Virginia, 23298
Status
Recruiting
Address
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Status
Not yet recruiting
Address
Local Institution - 0005
Brisbane, Queensland, 4029
Status
Recruiting
Address
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Status
Recruiting
Address
The Alfred Hospital
Melbourne, Victoria, 3004
Status
Recruiting
Address
St Vincent's Hospital
Melbourne, Victoria, 3065
Status
Recruiting
Address
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Status
Recruiting
Address
Uniklinikum Salzburg
Salzburg, , 5020
Status
Recruiting
Address
Medizinische Universität Wien
Wien, , 1090
Status
Recruiting
Address
Institut Jules Bordet
Anderlecht, Bruxelles-Capitale, Région De, 1070
Status
Recruiting
Address
UZ Brussel
Brussels, Bruxelles-Capitale, Région De, 1090
Status
Not yet recruiting
Address
Local Institution - 0133
Edmonton, Alberta, T6G 1Z2
Status
Recruiting
Address
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario, L8V5C2
Status
Not yet recruiting
Address
Local Institution - 0134
Montreal, Quebec, H1T 2M4
Status
Not yet recruiting
Address
Local Institution - 0036
Brno, Brno-město, 625 00
Status
Not yet recruiting
Address
Local Institution - 0034
Hradec Kralove, Hradec Králové, 500 05
Status
Not yet recruiting
Address
Local Institution - 0035
Olomouc, Olomoucký Kraj, 779 00
Status
Not yet recruiting
Address
Local Institution - 0033
Praha 2, , 12808
Status
Not yet recruiting
Address
Local Institution - 0070
Odense, Syddanmark, 5000
Status
Recruiting
Address
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33600
Status
Recruiting
Address
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône, 13273
Status
Recruiting
Address
Hopital Claude Huriez - CHU de Lille
Lille, Nord, 59000
Status
Recruiting
Address
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Pays-de-la-Loire, 44000
Status
Recruiting
Address
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, 69310
Status
Recruiting
Address
Henri Mondor Hospital
Créteil, Val-de-Marne, 94010
Status
Recruiting
Address
Gustave Roussy
Villejuif, Val-de-Marne, 94805
Status
Recruiting
Address
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, 86021
Status
Recruiting
Address
Hôpital Saint-Louis
Paris, , 75010
Status
Recruiting
Address
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, , 31100
Status
Recruiting
Address
Hôpital Saint Antoine
Paris, Île-de-France, 75571
Status
Not yet recruiting
Address
Local Institution - 0072
Heidelberg, Baden-Württemberg, 69120
Status
Not yet recruiting
Address
Local Institution - 0078
Ulm, Baden-Württemberg, 89081
Status
Not yet recruiting
Address
Local Institution - 0077
Nuremberg, Bayern, 90419
Status
Not yet recruiting
Address
Local Institution - 0073
Köln, Nordrhein-Westfalen, 50937
Status
Not yet recruiting
Address
Local Institution - 0079
Dresden, Sachsen, 01307
Status
Not yet recruiting
Address
Local Institution - 0087
Leipzig, Sachsen, 04103
Status
Not yet recruiting
Address
Local Institution - 0075
Kiel, Schleswig-Holstein, 24105
Status
Not yet recruiting
Address
Local Institution - 0115
Essen, , 45122
Status
Not yet recruiting
Address
Local Institution - 0076
Hamburg, , 20246
Status
Not yet recruiting
Address
Local Institution - 0074
Wuerzburg, , 97080
Status
Recruiting
Address
University Hospital of Patras
Patras, Achaḯa, 26504
Status
Recruiting
Address
Evangelismos General Hospital of Athens
Athens, Attikí, 106 76
Status
Recruiting
Address
Attikon General University Hospital
Chaidari, Attikí, 12462
Status
Recruiting
Address
G. Papanikolaou General Hospital
Thessaloniki, Thessaloníki, 570 10
Status
Not yet recruiting
Address
Local Institution - 0055
Be'er Sheva, HaDarom, 8410101
Status
Not yet recruiting
Address
Local Institution - 0058
Petah-Tikva, HaMerkaz, 4910021
Status
Recruiting
Address
Sheba Medical Center
Ramat Gan, HaMerkaz, 5262100
Status
Recruiting
Address
Sourasky Medical Center
Tel Aviv, Tell Abīb, 6423906
Status
Recruiting
Address
Rambam Health Care Campus
Haifa, , 31096
Status
Recruiting
Address
Hadassah Medical Center
Jerusalem, , 9112001
Status
Recruiting
Address
Humanitas
Rozzano, Milano, 20089
Status
Not yet recruiting
Address
Local Institution - 0067
Torino, Piemonte, 10126
Status
Recruiting
Address
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, , 40138
Status
Recruiting
Address
AOU Policlinico Umberto I
Roma, , 00161
Status
Recruiting
Address
Nagoya City University Hospital
Nagoya, Aichi, 467-8602
Status
Recruiting
Address
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Status
Recruiting
Address
Hyogo Medical University Hospital
Nishinomiya, Hyogo, 663-8501
Status
Recruiting
Address
Kanazawa University Hospital
Kanazawa, Ishikawa, 920-8641
Status
Recruiting
Address
Tokai University Hospital
Isehara, Kanagawa, 259-1193
Status
Recruiting
Address
Chiba University Hospital
Chiba, , 260-8677
Status
Not yet recruiting
Address
Local Institution - 0054
Fukuoka, , 812-8582
Status
Recruiting
Address
Okayama University Hospital
Okayama, , 700-8558
Status
Not yet recruiting
Address
Local Institution - 0071
Shimotsuke, , 329-0498
Status
Not yet recruiting
Address
Local Institution - 0050
Tokyo, , 150-8935
Status
Not yet recruiting
Address
Local Institution - 0041
Hwasun Gun, Jeonranamdo, 58128
Status
Not yet recruiting
Address
Local Institution - 0039
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Status
Not yet recruiting
Address
Local Institution - 0040
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Status
Not yet recruiting
Address
Local Institution - 0038
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Status
Not yet recruiting
Address
Local Institution - 0043
Seoul, Seoul-teukbyeolsi [Seoul], 06591
Status
Recruiting
Address
Oslo Universitetssykehus Rikshospitalet
Oslo, , 0372
Status
Recruiting
Address
Centrum Onkologii Ziemi Lubelskiej
Lublin, Lubelskie, 20-090
Status
Recruiting
Address
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw, Mazowieckie, 02-097
Status
Recruiting
Address
Instytut Hematologii i Transfuzjologii
Warsaw, Mazowieckie, 02-776
Status
Recruiting
Address
Uniwersyteckie Centrum Kliniczne
Gdańsk, , 80-952
Status
Recruiting
Address
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznań, , 60-569
Status
Recruiting
Address
Narodowy Instytut Onkologii - Oddzial w Gliwicach
Gliwice, Śląskie, 44-101
Status
Recruiting
Address
Institutul Clinic Fundeni
Bucharest, , 022328
Status
Recruiting
Address
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [Barcelona], 08916
Status
Recruiting
Address
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona [Barcelona], 08908
Status
Recruiting
Address
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], 08036
Status
Recruiting
Address
Clinica Universidad de Navarra
Pamplona, Navarra, 31008
Status
Recruiting
Address
Hospital Universitario 12 de Octubre
Madrid, , 28041
Status
Recruiting
Address
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, , 37007
Status
Recruiting
Address
Hospital Universitari i Politecnic La Fe
València, , 46026
Status
Not yet recruiting
Address
Local Institution - 0093
Birmingham, England, B15 2TH
Status
Not yet recruiting
Address
Local Institution - 0080
London, London, City Of, SE5 9RS
Status
Not yet recruiting
Address
Local Institution - 0094
London, London, City Of, W12 0HS
Status
Not yet recruiting
Address
Local Institution - 0081
Glasgow, , G12 0YN