An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants
NCT ID: NCT02761187
Last Updated: 2025-02-24
Study Results
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View full resultsBasic Information
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TERMINATED
4253 participants
OBSERVATIONAL
2016-07-01
2021-09-30
Brief Summary
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Detailed Description
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The study will enroll approximately 4200 participants. Participants will be assigned to one of the following cohorts based upon the diagnosis of MM:
* ND MM within 3 months from initiation of treatment
* R/R MM who have received 1 to 3 prior lines of therapy
This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 8 years. Participants will be evaluated and followed-up for a period of at least 5 years, until death, are lost to follow-up, or the end of the study, whichever comes first.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Newly Diagnosed Multiple Myeloma
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
No Intervention
As this was an observational study, no intervention was administered.
Relapsed/Refractory Multiple Myeloma
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
No Intervention
As this was an observational study, no intervention was administered.
Interventions
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No Intervention
As this was an observational study, no intervention was administered.
Eligibility Criteria
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Inclusion Criteria
Is experiencing the following:
1. Newly diagnosed MM within 3 months from initiation of treatment with documented month and year of diagnosis, criteria met for diagnosis, stage, and MM-directed treatment history, including duration, or
2. Relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy, whether consolidation/maintenance was part of 1st, 2nd, and 3rd line of therapy, also whether investigational therapy/treated on a clinical trial was part of any of these regimens.
Is willing and able to sign informed consent to participate. Is willing and able to complete patient-reported outcomes (PROs) in accordance with local regulatory and data protection requirements.
Exclusion Criteria
Has participated in another study (observational or interventional) that prohibits participation in this study.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Locations
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CARTI Cancer Center
Little Rock, Arkansas, United States
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States
University of California San Diego
La Jolla, California, United States
St Joseph Heritage Healthcare
Santa Rosa, California, United States
Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado, United States
Poudre Valley Health System
Fort Collins, Colorado, United States
George Washington University
Washington D.C., District of Columbia, United States
SCRI Florida Cancer Specialists East
Daytona Beach, Florida, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States
SCRI Florida Cancer Specialists North
St. Petersburg, Florida, United States
Illinois Cancer Specialists (Niles) - USOR
Niles, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
Central Maine Medical Center
Lewiston, Maine, United States
Maryland Oncology Hematology (Columbia) - USOR
Columbia, Maryland, United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, United States
Central Care Cancer Center
Bolivar, Missouri, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
Hunterdon Hematology Oncology
Flemington, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Saint Francis Hospital
East Hills, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Levine Cancer Center
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Hematology Oncology Associates - USOR
Medford, Oregon, United States
Northwest Cancer Specialists (Broadway) - USOR
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Veterans Affairs Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Greenville Health System Cancer Institute
Greenville, South Carolina, United States
SCRI Tennessee Oncology Nashville
Nashville, Tennessee, United States
Texas Oncology (Loop) - USOR
Amarillo, Texas, United States
Texas Oncology (Loop) - USOR
Dallas, Texas, United States
Texas Oncology (Loop) - USOR
El Paso, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology (Loop) - USOR
Round Rock, Texas, United States
Texas Oncology (Loop) - USOR
San Antonio, Texas, United States
Yakima Valley Memorial Hospital North Star Lodge - USOR
Yakima, Washington, United States
Berkeley Medical Center
Martinsburg, West Virginia, United States
St Vincent Hospital
Green Bay, Wisconsin, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Milwaukee, Wisconsin, United States
Grand Hopital de Charleroi asbl
Charleroi, , Belgium
UZ Gent
Ghent, , Belgium
Hopital de Jolimont
Haine-Saint-Paul, , Belgium
UZ Leuven
Leuven, , Belgium
CHU de Liege
Liège, , Belgium
CHU UCL Namur asbl - Site Godinne
Yvoir, , Belgium
Unicamp Universidade Estadual de Campinas
Campinas, , Brazil
Centro de Pesquisas Oncologicas
Florianópolis, , Brazil
Hospital Das Clinicas Da Universidade Federal de Goias
Goiânia, , Brazil
Universidade Federal Do Rio de Janeiro Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, , Brazil
CEHON - Centro de Hematologia e Oncologia da Bahia Ltda
Salvador, , Brazil
Clinica Sao Germano
São Paulo, , Brazil
Hospital Israelita Albert Einstein
São Paulo, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, , Brazil
Peking Union Medical College Hospital
Beijing, , China
Peking University Peoples Hospital
Beijing, , China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, , China
First Affiliated Hospital of Soochow University
Suzhou, , China
Fundacion Santa Fe de Bogota
Bogotá, , Colombia
Fundacion Oftalmologica de Santander Foscal
Floridablanca, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Oncomedica SA
Montería, , Colombia
Centre Hospitalier de La Cote Basque
Bayonne, , France
Centre Hospitalier Departemental de Vendee
La Roche-sur-Yon, , France
Centre Hospitalier Le Mans
Le Mans, , France
Centre Hospitalier de Perigueux
Périgueux, , France
CHRU de Poitiers La Miletrie
Poitiers, , France
CHU de Nancy-Hopital Brabois Adulte
Vandœuvre-lès-Nancy, , France
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Gefos - Gesellschaft fur onkologische Studien mbH
Dortmund, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Internistisch Hamatologische und Internistische Praxis
Herrsching am Ammersee, , Germany
Institut fur Versorgungsforschung in der Onkologie GbR
Koblenz, , Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, , Germany
Mannheimer Onkologie Praxis
Mannheim, , Germany
OnkoNet Marburg GmbH
Marburg, , Germany
Onkologische Gemeinschaftspraxis Siegburg
Siegburg, , Germany
Universitatsklinikum Tubingen
Tübingen, , Germany
University Hospital of Alexandroupolis
Alexandroupoli, , Greece
Evangelismos General Hospital of Athens
Athens, , Greece
Alexandra Hospital
Athens, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
University General Hospital of Larissa
Larissa, , Greece
University General Hospital of Patras
Pátrai, , Greece
HaEmek Medical Center
Afula, , Israel
Lady Davis Carmel Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Meir Medical Center
Kefar Sava, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Assuta Medical Centers
Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona, , Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, , Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Policlinico Umberto I
Roma, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, , Italy
Azienda Sanitaria Universitaria Integrata di Udine
Udine, , Italy
Nucleo Oncologico de Occidente S.C.
Guadalajara, , Mexico
Hematologica Alta Especialidad S.C.
Huixquilucan, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, , Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, , Mexico
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Complejo Asistencial Universitario de Leon
León, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
Buzi, Chiayi County, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
Adana, , Turkey (Türkiye)
Ankara University Medical Faculty Cebeci Hospital
Ankara, , Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, , Turkey (Türkiye)
Johns Hopkins Medicine - Anadolu Saglik Merkezi
Gebze, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, , Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, , Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, , Turkey (Türkiye)
Karadeniz Technical University Faculty of Medicine
Trabzon, , Turkey (Türkiye)
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom
Royal United Hospital
Bath, , United Kingdom
University Hospital Birmingham
Birmingham, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Ninewells Hospital - PPDS
Dundee, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Pinderfields General Hospital
Wakefield, , United Kingdom
Countries
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References
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Rifkin RM, Costello CL, Birhiray RE, Kambhampati S, Richter J, Abonour R, Lee HC, Stokes M, Ren K, Stull DM, Cherepanov D, Bogard K, Noga SJ, Girnius S. In-class transition from bortezomib-based therapy to IRd is an effective approach in newly diagnosed multiple myeloma. Future Oncol. 2024 Jan;20(3):131-143. doi: 10.2217/fon-2023-0272. Epub 2023 Oct 9.
Thompson MA, Boccadoro M, Leleu X, Vela-Ojeda J, van Rhee F, Weisel KC, Rifkin RM, Usmani SZ, Hajek R, Cook G, Abonour R, Armour M, Morgan KE, Yeh SP, Costello CL, Berdeja JG, Davies FE, Zonder JA, Lee HC, Omel J, Spencer A, Terpos E, Hungria VTM, Puig N, Fu C, Ferrari RH, Ren K, Stull DM, Chari A. Rates of Influenza and Pneumococcal Vaccination and Correlation With Survival in Multiple Myeloma Patients. Clin Lymphoma Myeloma Leuk. 2023 Mar;23(3):e171-e181. doi: 10.1016/j.clml.2022.12.003. Epub 2022 Dec 7.
Hajek R, Minarik J, Straub J, Pour L, Jungova A, Berdeja JG, Boccadoro M, Brozova L, Spencer A, van Rhee F, Vela-Ojeda J, Thompson MA, Abonour R, Chari A, Cook G, Costello CL, Davies FE, Hungria VT, Lee HC, Leleu X, Puig N, Rifkin RM, Terpos E, Usmani SZ, Weisel KC, Zonder JA, Barinova M, Kuhn M, Silar J, Capkova L, Galvez K, Lu J, Elliott J, Stull DM, Ren K, Maisnar V. Ixazomib-lenalidomide-dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma. Future Oncol. 2021 Jul;17(19):2499-2512. doi: 10.2217/fon-2020-1225. Epub 2021 Mar 26.
Costello C, Davies FE, Cook G, Vela-Ojeda J, Omel J, Rifkin RM, Berdeja J, Puig N, Usmani SZ, Weisel K, Zonder JA, Terpos E, Spencer A, Leleu X, Boccadoro M, Thompson MA, Romanus D, Stull DM, Hungria V. INSIGHT MM: a large, global, prospective, non-interventional, real-world study of patients with multiple myeloma. Future Oncol. 2019 May;15(13):1411-1428. doi: 10.2217/fon-2019-0013. Epub 2019 Feb 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NSMM-5001
Identifier Type: -
Identifier Source: org_study_id
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