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 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 transplant ation (ASCT).
View Eligibility Criteria Eligibility Criteria Inclusion Criteria Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received treatment -for-multiple-myeloma-induction-therapy/" >induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN. Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction. Participant must have documented response of PR or VGPR at time of consent. Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion). Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy. Exclusion Criteria Participant with known central nervous system involvement with myeloma. Participant has non-secretory MM. Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection. Participant has history of primary immunodeficiency. Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy. Other protocol-defined Inclusion/Exclusion criteria apply.
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There are 115 Locations for this study
Banner MD Anderson Cancer Center Gilbert Arizona, 85234, United States
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Mayo Clinic in Arizona - Scottsdale Scottsdale Arizona, 85259, United States
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UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) Los Angeles California, 90095, United States
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University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange California, 92868, United States
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University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento California, 95817, United States
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Colorado Blood Cancer Institute Denver Colorado, 80218, United States
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Yale University School of Medicine New Haven Connecticut, 06510, United States
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Mayo Clinic in Florida Jacksonville Florida, 32224, United States
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AdventHealth Orlando Orlando Florida, 32804, United States
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Moffitt Cancer Center Tampa Florida, 33612, United States
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Winship Cancer Institute, Emory University Atlanta Georgia, 30322, United States
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Northside Hospital Atlanta Georgia, 30342, United States
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Massachusetts General Hospital Boston Massachusetts, 02114, United States
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Boston Medical Center Boston Massachusetts, 02118, United States
Local Institution - 0123 Ann Arbor Michigan, 48109, United States
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Ascension Providence Hospital Southfield Michigan, 48075, United States
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Local Institution - 0119 Minneapolis Minnesota, 55455, United States
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Mayo Clinic in Rochester, Minnesota Rochester Minnesota, 55905, United States
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Washington University School of Medicine Saint Louis Missouri, 63110, United States
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Washington University School of Medicine Saint Louis Missouri, 63110, United States
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Columbia University Irving Medical Center New York New York, 10032, United States
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Novant Health Cancer Institute - Elizabeth Charlotte North Carolina, 28204, United States
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Wake Forest Baptist Health Winston-Salem North Carolina, 27157, United States
University Hospitals Cleveland Medical Center Cleveland Ohio, 44106, United States
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The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus Ohio, 43210, United States
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Hospital of the University of Pennsylvania Philadelphia Pennsylvania, 19104, United States
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St. David's South Austin Medical Center Austin Texas, 78704, United States
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UT Southwestern Medical Center Dallas Texas, 75390, United States
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Houston Methodist Hospital Houston Texas, 77030, United States
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University of Texas MD Anderson Cancer Center Houston Texas, 77030, United States
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Local Institution - 0136 Richmond Virginia, 23298, United States
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Royal Prince Alfred Hospital Camperdown New South Wales, 2050, Australia
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Local Institution - 0005 Brisbane Queensland, 4029, Australia
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Peter MacCallum Cancer Centre Melbourne Victoria, 3000, Australia
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The Alfred Hospital Melbourne Victoria, 3004, Australia
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St Vincent's Hospital Melbourne Victoria, 3065, Australia
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Fiona Stanley Hospital Murdoch Western Australia, 6150, Australia
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Uniklinikum Salzburg Salzburg , 5020, Austria
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Medizinische Universität Wien Wien , 1090, Austria
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Institut Jules Bordet Anderlecht Bruxelles-Capitale, Région De, 1070, Belgium
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UZ Brussel Brussels Bruxelles-Capitale, Région De, 1090, Belgium
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Local Institution - 0133 Edmonton Alberta, T6G 1, Canada
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Hamilton Health Sciences-Juravinski Cancer Centre Hamilton Ontario, L8V5C, Canada
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Local Institution - 0134 Montreal Quebec, H1T 2, Canada
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Local Institution - 0036 Brno Brno-město, 625 0, Czechia
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Local Institution - 0034 Hradec Kralove Hradec Králové, 500 0, Czechia
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Local Institution - 0035 Olomouc Olomoucký Kraj, 779 0, Czechia
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Local Institution - 0033 Praha 2 , 12808, Czechia
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Local Institution - 0070 Odense Syddanmark, 5000, Denmark
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CHU Bordeaux Haut-Leveque Pessac Aquitaine, 33600, France
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Institut Paoli-Calmettes Marseille Bouches-du-Rhône, 13273, France
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Hopital Claude Huriez - CHU de Lille Lille Nord, 59000, France
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Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes Pays-de-la-Loire, 44000, France
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Centre Hospitalier Lyon Sud Pierre-Bénite Rhône, 69310, France
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Henri Mondor Hospital Créteil Val-de-Marne, 94010, France
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Gustave Roussy Villejuif Val-de-Marne, 94805, France
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Centre Hospitalier Universitaire de Poitiers Poitiers Vienne, 86021, France
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Hôpital Saint-Louis Paris , 75010, France
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Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE Toulouse , 31100, France
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Hôpital Saint Antoine Paris Île-de-France, 75571, France
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Local Institution - 0072 Heidelberg Baden-Württemberg, 69120, Germany
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Local Institution - 0078 Ulm Baden-Württemberg, 89081, Germany
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Local Institution - 0077 Nuremberg Bayern, 90419, Germany
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Local Institution - 0073 Köln Nordrhein-Westfalen, 50937, Germany
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Local Institution - 0079 Dresden Sachsen, 01307, Germany
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Local Institution - 0087 Leipzig Sachsen, 04103, Germany
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Local Institution - 0075 Kiel Schleswig-Holstein, 24105, Germany
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Local Institution - 0115 Essen , 45122, Germany
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Local Institution - 0076 Hamburg , 20246, Germany
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Local Institution - 0074 Wuerzburg , 97080, Germany
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University Hospital of Patras Patras Achaḯa, 26504, Greece
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Evangelismos General Hospital of Athens Athens Attikí, 106 7, Greece
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Attikon General University Hospital Chaidari Attikí, 12462, Greece
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G. Papanikolaou General Hospital Thessaloniki Thessaloníki, 570 1, Greece
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Soroka Medical Center Be'er Sheva HaDarom, 84101, Israel
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Local Institution - 0058 Petah-Tikva HaMerkaz, 49100, Israel
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Sheba Medical Center Ramat Gan HaMerkaz, 52621, Israel
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Sourasky Medical Center Tel Aviv Tell Abīb, 64239, Israel
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Rambam Health Care Campus Haifa , 31096, Israel
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Hadassah Medical Center Jerusalem , 91120, Israel
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Humanitas Rozzano Milano, 20089, Italy
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Local Institution - 0067 Torino Piemonte, 10126, Italy
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IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna , 40138, Italy
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AOU Policlinico Umberto I Roma , 00161, Italy
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Nagoya City University Hospital Nagoya Aichi, 467-8, Japan
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Hokkaido University Hospital Sapporo Hokkaido, 060-8, Japan
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Hyogo Medical University Hospital Nishinomiya Hyogo, 663-8, Japan
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Kanazawa University Hospital Kanazawa Ishikawa, 920-8, Japan
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Tokai University Hospital Isehara Kanagawa, 259-1, Japan
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Chiba University Hospital Chiba , 260-8, Japan
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Local Institution - 0054 Fukuoka , 812-8, Japan
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Okayama University Hospital Okayama , 700-8, Japan
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Jichi Medical University Hospital Shimotsuke , 329-0, Japan
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Local Institution - 0050 Tokyo , 150-8, Japan
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Chonnam National University Hwasun Hospital Hwasun Jeonranamdo, 58128, Korea, Republic of
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Seoul National University Hospital Seoul Seoul Teugbyeolsi, 03080, Korea, Republic of
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Samsung Medical Center Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
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The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of
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Local Institution - 0040 Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of
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Oslo Universitetssykehus Rikshospitalet Oslo , 0372, Norway
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Centrum Onkologii Ziemi Lubelskiej Lublin Lubelskie, 20-09, Poland
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Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Warsaw Mazowieckie, 02-09, Poland
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Instytut Hematologii i Transfuzjologii Warsaw Mazowieckie, 02-77, Poland
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Uniwersyteckie Centrum Kliniczne Gdańsk , 80-95, Poland
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Uniwersytecki Szpital Kliniczny w Poznaniu Poznań , 60-56, Poland
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Narodowy Instytut Onkologii - Oddzial w Gliwicach Gliwice Śląskie, 44-10, Poland
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Institutul Clinic Fundeni Bucharest , 02232, Romania
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Institut Català d'Oncologia (ICO) - Badalona Badalona Barcelona [Barcelona], 08916, Spain
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Institut Català d'Oncologia - L'Hospitalet L'Hospitalet Del Llobregat Barcelona [Barcelona], 08908, Spain
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Hospital Clínic de Barcelona Barcelona Catalunya [Cataluña], 08036, Spain
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Clinica Universidad de Navarra Pamplona Navarra, 31008, Spain
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Hospital Universitario 12 de Octubre Madrid , 28041, Spain
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Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca Salamanca , 37007, Spain
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Hospital Universitari i Politecnic La Fe València , 46026, Spain
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Queen Elizabeth Hospital Birmingham Birmingham England, B15 2, United Kingdom
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Local Institution - 0080 London London, City Of, SE5 9, United Kingdom
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Local Institution - 0094 London London, City Of, W12 0, United Kingdom
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Local Institution - 0081 Glasgow , G12 0, United Kingdom
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