Multiple Myeloma Clinical Trial

An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants

Summary

The purpose of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed [ND] multiple myeloma (MM) and participants with relapsed/refractory [R/R] MM.

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Full Description

This is a prospective, non-interventional, observational study. This study will look at contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with MM. Participants will not be asked to change their routine clinical treatment. Participants will have to complete patient reported outcomes (PROs) surveys during on-site routine office visits.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Is 18 years of age or older.

Is experiencing the following:

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
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:

Is reporting to a site in this study for a second opinion (consultation only) or participants whose frequency of consult and follow-up are not adequate for quarterly electronic case report form (eCRF) completion.

Has participated in another study (observational or interventional) that prohibits participation in this study.

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

4310

Study ID:

NCT02761187

Recruitment Status:

Completed

Sponsor:

Takeda

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There are 103 Locations for this study

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CARTI Cancer Center
Little Rock Arkansas, 72205, United States
University of Arkansas For Medical Sciences
Little Rock Arkansas, 72205, United States
University of California San Diego
La Jolla California, 92093, United States
St Joseph Heritage Healthcare
Santa Rosa California, 95403, United States
Rocky Mountain Cancer Centers (Williams) - USOR
Denver Colorado, 80218, United States
Poudre Valley Health System
Fort Collins Colorado, 80528, United States
George Washington University
Washington District of Columbia, 20037, United States
SCRI Florida Cancer Specialists East
Daytona Beach Florida, 32117, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
SCRI Florida Cancer Specialists North
Saint Petersburg Florida, 33705, United States
Illinois Cancer Specialists (Niles) - USOR
Niles Illinois, 60714, United States
Indiana University
Indianapolis Indiana, 46202, United States
East Jefferson General Hospital
Metairie Louisiana, 70006, United States
Central Maine Medical Center
Lewiston Maine, 04240, United States
Maryland Oncology Hematology (Columbia) - USOR
Columbia Maryland, 21044, United States
Barbara Ann Karmanos Cancer Center
Detroit Michigan, 48201, United States
Park Nicollet Institute
Saint Louis Park Minnesota, 55416, United States
Central Care Cancer Center
Bolivar Missouri, 65613, United States
Kansas City VA Medical Center
Kansas City Missouri, 64128, United States
Washington University in St. Louis
Saint Louis Missouri, 63110, United States
Hunterdon Hematology Oncology
Flemington New Jersey, 08822, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
Saint Francis Hospital
East Hills New York, 11576, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Levine Cancer Center
Charlotte North Carolina, 28402, United States
University of Cincinnati
Cincinnati Ohio, 45220, United States
Hematology Oncology Associates - USOR
Medford Oregon, 97504, United States
Northwest Cancer Specialists (Broadway) - USOR
Portland Oregon, 97227, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Veterans Affairs Pittsburgh Healthcare System
Pittsburgh Pennsylvania, 15240, United States
Greenville Health System Cancer Institute
Greenville South Carolina, 29615, United States
SCRI Tennessee Oncology Nashville
Nashville Tennessee, 37203, United States
Texas Oncology (Loop) - USOR
Amarillo Texas, 79106, United States
Texas Oncology (Loop) - USOR
Dallas Texas, 92056, United States
Texas Oncology (Loop) - USOR
El Paso Texas, 79902, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Texas Oncology (Loop) - USOR
Round Rock Texas, 78681, United States
Texas Oncology (Loop) - USOR
San Antonio Texas, 78217, United States
Yakima Valley Memorial Hospital North Star Lodge - USOR
Yakima Washington, 98902, United States
Berkeley Medical Center
Martinsburg West Virginia, 25401, United States
St Vincent Hospital
Green Bay Wisconsin, 54307, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States
Aurora Health Care, Aurora Cancer Care
Milwaukee Wisconsin, 53215, United States
Grand Hopital de Charleroi asbl
Charleroi , 6000, Belgium
UZ Gent
Gent , 9000, Belgium
Hopital de Jolimont
Haine-Saint-Paul , 7100, Belgium
UZ Leuven
Leuven , 3000, Belgium
CHU de Liege
Liege , 4000, Belgium
CHU UCL Namur asbl - Site Godinne
Yvoir , 5530, Belgium
Unicamp Universidade Estadual de Campinas
Campinas , 13083, Brazil
Centro de Pesquisas Oncologicas
Florianopolis , 88034, Brazil
Hospital Das Clinicas Da Universidade Federal de Goias
Goiania , 74680, Brazil
Universidade Federal Do Rio de Janeiro Hospital Universitario Clementino Fraga Filho
Rio de Janeiro , 21941, Brazil
CEHON - Centro de Hematologia e Oncologia da Bahia Ltda
Salvador , 40110, Brazil
Clinica Sao Germano
Sao Paulo , 04537, Brazil
Hospital Israelita Albert Einstein
Sao Paulo , 05651, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo , 54030, Brazil
Peking Union Medical College Hospital
Beijing , 10073, China
Peking University Peoples Hospital
Beijing , , China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou , 31000, China
First Affiliated Hospital of Soochow University
Suzhou , 21500, China
Fundacion Santa Fe de Bogota
Bogota , , Colombia
Fundacion Oftalmologica de Santander Foscal
Floridablanca , , Colombia
Hospital Pablo Tobon Uribe
Medellin , , Colombia
Oncomedica SA
Monteria , , Colombia
Centre Hospitalier de La Cote Basque
Bayonne , 64109, France
Centre Hospitalier Le Mans
Le Mans , 72000, France
Centre Hospitalier de Perigueux
Perigueux , 24019, France
CHRU de Poitiers La Miletrie
Poitiers , 86021, France
Centre Hospitalier Departemental de Vendee
Roche-sur-Yon , 85000, France
CHU de Nancy-Hopital Brabois Adulte
Vandoeuvre-les-nancy , 54211, 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
Tubingen , , Germany
University Hospital of Alexandroupolis
Alexandroupoli , 68100, Greece
Evangelismos General Hospital of Athens
Athens , 10676, Greece
Alexandra Hospital
Athens , 11525, Greece
University General Hospital of Ioannina
Ioannina , 45500, Greece
University General Hospital of Larissa
Larisa , 41110, Greece
University General Hospital of Patras
Patras , 26500, Greece
HaEmek Medical Center
Afula , 18371, Israel
Lady Davis Carmel Medical Center
Haifa , 34362, Israel
Shaare Zedek Medical Center
Jerusalem , , Israel
Meir Medical Center
Kefar-Sava , 44281, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Assuta Medical Centers
Tel Aviv , 69710, Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona , 60020, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna , 40138, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania , , Italy
Azienda Ospedaliera Universitaria Careggi
Firenze , 50134, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli , , Italy
Azienda Policlinico Umberto I
Roma , 00161, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino , , Italy
Azienda Sanitaria Universitaria Integrata di Udine
Udine , 33100, Italy
Nucleo Oncologico de Occidente S.C.
Guadalajara , 44670, Mexico
Hematologica Alta Especialidad S.C.
Huixquilucan , , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City , 14000, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey , 64460, Mexico
Hospital Clinic de Barcelona
Barcelona , 8036, Spain
Hospital Universitario Virgen de Las Nieves
Granada , 18014, Spain
Complejo Asistencial Universitario de Leon
Leon , 24080, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , , Spain
Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
Puzi Chiayi County, 613, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung , 807, Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , , Taiwan
China Medical University Hospital
Taichung City , 40447, Taiwan
National Cheng Kung University Hospital
Tainan , 70403, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
Adana , , Turkey
Ankara University Medical Faculty Cebeci Hospital
Ankara , , Turkey
Akdeniz University Medical Faculty
Antalya , , Turkey
Johns Hopkins Medicine - Anadolu Saglik Merkezi
Gebze , , Turkey
Ege Universitesi Tip Fakultesi Hastanesi
Istanbul , , Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul , , Turkey
Dokuz Eylul University Medical Faculty
Izmir , , Turkey
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri , , Turkey
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun , , Turkey
Karadeniz Technical University Faculty of Medicine
Trabzon , , Turkey
Leeds Teaching Hospitals NHS Trust
Leeds West Yorkshire, LS1 3, United Kingdom
Royal United Hospital
Bath , , United Kingdom
University Hospital Birmingham
Birmingham , B15 2, United Kingdom
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
Royal Bournemouth Hospital
Bournemouth , Bh7 7, United Kingdom
Ninewells Hospital - PPDS
Dundee , DD1 9, United Kingdom
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham , NG5 1, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton , SM2 5, United Kingdom
Pinderfields General Hospital
Wakefield , WF1 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

4310

Study ID:

NCT02761187

Recruitment Status:

Completed

Sponsor:


Takeda

How clear is this clinincal trial information?

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