Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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)
Study ID: NCT06045806
Conditions
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic in Arizona - Scottsdale, Scottsdale, Arizona, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120), Los Angeles, California, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center, Orange, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center, Sacramento, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Northside Hospital, Atlanta, Georgia, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Boston Medical Center, Boston, Massachusetts, United States
Local Institution - 0123, Ann Arbor, Michigan, United States
Ascension Providence Hospital, Southfield, Michigan, United States
Local Institution - 0119, Minneapolis, Minnesota, United States
Mayo Clinic in Rochester, Minnesota, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, 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
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
St. David's South Austin Medical Center, Austin, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Houston Methodist Hospital, Houston, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Local Institution - 0136, Richmond, Virginia, United States
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Local Institution - 0005, Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
St Vincent's Hospital, Melbourne, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Uniklinikum Salzburg, Salzburg, , Austria
Medizinische Universität Wien, Wien, , Austria
Institut Jules Bordet, Anderlecht, Bruxelles-Capitale, Région De, Belgium
UZ Brussel, Brussels, Bruxelles-Capitale, Région De, Belgium
Local Institution - 0133, Edmonton, Alberta, Canada
Hamilton Health Sciences-Juravinski Cancer Centre, Hamilton, Ontario, Canada
Local Institution - 0134, Montreal, Quebec, Canada
Local Institution - 0036, Brno, Brno-město, Czechia
Local Institution - 0034, Hradec Kralove, Hradec Králové, Czechia
Local Institution - 0035, Olomouc, Olomoucký Kraj, Czechia
Local Institution - 0033, Praha 2, , Czechia
Local Institution - 0070, Odense, Syddanmark, Denmark
CHU Bordeaux Haut-Leveque, 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
Centre Hospitalier Lyon Sud, Pierre-Bénite, Rhône, France
Henri Mondor Hospital, Créteil, Val-de-Marne, France
Gustave Roussy, Villejuif, Val-de-Marne, France
Centre Hospitalier Universitaire de Poitiers, Poitiers, Vienne, France
Hôpital Saint-Louis, Paris, , France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE, Toulouse, , France
Hôpital Saint Antoine, 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 - 0079, Dresden, Sachsen, Germany
Local Institution - 0087, Leipzig, Sachsen, Germany
Local Institution - 0075, Kiel, Schleswig-Holstein, Germany
Local Institution - 0115, Essen, , Germany
Local Institution - 0076, Hamburg, , Germany
Local Institution - 0074, Wuerzburg, , Germany
University Hospital of Patras, Patras, Achaḯa, Greece
Evangelismos General Hospital of Athens, Athens, Attikí, Greece
Attikon General University Hospital, Chaidari, Attikí, Greece
G. Papanikolaou General Hospital, Thessaloniki, Thessaloníki, Greece
Soroka Medical Center, Be'er Sheva, HaDarom, Israel
Local Institution - 0058, Petah-Tikva, HaMerkaz, Israel
Sheba Medical Center, Ramat Gan, HaMerkaz, Israel
Sourasky Medical Center, Tel Aviv, Tell Abīb, Israel
Rambam Health Care Campus, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Humanitas, Rozzano, Milano, Italy
Local Institution - 0067, Torino, Piemonte, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, Bologna, , Italy
AOU Policlinico Umberto I, Roma, , Italy
Nagoya City University Hospital, Nagoya, Aichi, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Hyogo Medical University Hospital, Nishinomiya, Hyogo, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Tokai University Hospital, Isehara, Kanagawa, Japan
Chiba University Hospital, Chiba, , Japan
Local Institution - 0054, Fukuoka, , Japan
Okayama University Hospital, Okayama, , Japan
Jichi Medical University Hospital, Shimotsuke, , Japan
Local Institution - 0050, Tokyo, , Japan
Chonnam National University Hwasun Hospital, Hwasun, Jeonranamdo, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Local Institution - 0040, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Oslo Universitetssykehus Rikshospitalet, Oslo, , Norway
Centrum Onkologii Ziemi Lubelskiej, Lublin, Lubelskie, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie, Warsaw, Mazowieckie, Poland
Instytut Hematologii i Transfuzjologii, Warsaw, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu, Poznań, , Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach, Gliwice, Śląskie, Poland
Institutul Clinic Fundeni, Bucharest, , Romania
Institut Català d'Oncologia (ICO) - Badalona, Badalona, Barcelona [Barcelona], Spain
Institut Català d'Oncologia - L'Hospitalet, L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain
Hospital Clínic de Barcelona, Barcelona, Catalunya [Cataluña], Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca, Salamanca, , Spain
Hospital Universitari i Politecnic La Fe, València, , Spain
Queen Elizabeth Hospital Birmingham, Birmingham, England, United Kingdom
Local Institution - 0080, London, London, City Of, United Kingdom
Local Institution - 0094, London, London, City Of, United Kingdom
Local Institution - 0081, Glasgow, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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