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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02761187
Other study ID # NSMM-5001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2016
Est. completion date September 30, 2021

Study information

Verified date February 2022
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4310
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Is 18 years of age or older. 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: 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No Intervention


Locations

Country Name City State
Belgium Grand Hopital de Charleroi asbl Charleroi
Belgium UZ Gent Gent
Belgium Hopital de Jolimont Haine-Saint-Paul
Belgium UZ Leuven Leuven
Belgium CHU de Liege Liege
Belgium CHU UCL Namur asbl - Site Godinne Yvoir
Brazil Unicamp Universidade Estadual de Campinas Campinas
Brazil Centro de Pesquisas Oncologicas Florianopolis
Brazil Hospital Das Clinicas Da Universidade Federal de Goias Goiania
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 Sao Paulo
Brazil Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Sao Paulo
Brazil Hospital Israelita Albert Einstein Sao Paulo
China 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
Colombia Fundacion Santa Fe de Bogota Bogota
Colombia Fundacion Oftalmologica de Santander Foscal Floridablanca
Colombia Hospital Pablo Tobon Uribe Medellin
Colombia Oncomedica SA Monteria
France Centre Hospitalier de La Cote Basque Bayonne
France Centre Hospitalier Le Mans Le Mans
France Centre Hospitalier de Perigueux Perigueux
France CHRU de Poitiers La Miletrie Poitiers
France Centre Hospitalier Departemental de Vendee Roche-sur-Yon
France CHU de Nancy-Hopital Brabois Adulte Vandoeuvre-les-nancy
Germany 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
Greece University Hospital of Alexandroupolis Alexandroupoli
Greece Alexandra Hospital Athens
Greece Evangelismos General Hospital of Athens Athens
Greece University General Hospital of Ioannina Ioannina
Greece University General Hospital of Larissa Larisa
Greece University General Hospital of Patras Patras
Israel HaEmek Medical Center Afula
Israel Lady Davis Carmel Medical Center Haifa
Israel Shaare Zedek Medical Center Jerusalem
Israel Meir Medical Center Kefar-Sava
Israel Assuta Medical Centers Tel Aviv
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Italy 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 Firenze
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
Mexico 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
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitario Virgen de Las Nieves Granada
Spain Complejo Asistencial Universitario de Leon Leon
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Universitari i Politecnic La Fe de Valencia Valencia
Taiwan Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital Kaohsiung
Taiwan Kaohsiung Medical University Hospital Kaohsiung
Taiwan Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital Puzi Chiayi County
Taiwan China Medical University Hospital Taichung City
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Turkey 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
United Kingdom Royal United Hospital Bath
United Kingdom Birmingham Heartlands Hospital Birmingham
United Kingdom University Hospital Birmingham Birmingham
United Kingdom Royal Bournemouth Hospital Bournemouth
United Kingdom Ninewells Hospital - PPDS Dundee
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds West Yorkshire
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 States Texas Oncology (Loop) - USOR Amarillo Texas
United States Central Care Cancer Center Bolivar Missouri
United States Levine Cancer Center Charlotte North Carolina
United States University of Cincinnati Cincinnati Ohio
United States Maryland Oncology Hematology (Columbia) - USOR Columbia Maryland
United States Texas Oncology (Loop) - USOR Dallas Texas
United States SCRI Florida Cancer Specialists East Daytona Beach Florida
United States Rocky Mountain Cancer Centers (Williams) - USOR Denver Colorado
United States Barbara Ann Karmanos Cancer Center Detroit Michigan
United States Saint Francis Hospital East Hills New York
United States Texas Oncology (Loop) - USOR El Paso Texas
United States San Juan Oncology Associates Farmington New Mexico
United States Hunterdon Hematology Oncology Flemington New Jersey
United States Poudre Valley Health System Fort Collins Colorado
United States SCRI Florida Cancer Specialists South Fort Myers Florida
United States St Vincent Hospital Green Bay Wisconsin
United States Greenville Health System Cancer Institute Greenville South Carolina
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Indiana University Indianapolis Indiana
United States Kansas City VA Medical Center Kansas City Missouri
United States University of California San Diego La Jolla California
United States Central Maine Medical Center Lewiston Maine
United States CARTI Cancer Center Little Rock Arkansas
United States University of Arkansas For Medical Sciences Little Rock Arkansas
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Berkeley Medical Center Martinsburg West Virginia
United States Hematology Oncology Associates - USOR Medford Oregon
United States East Jefferson General Hospital Metairie Louisiana
United States Aurora Health Care, Aurora Cancer Care Milwaukee Wisconsin
United States SCRI Tennessee Oncology Nashville Nashville Tennessee
United States Mount Sinai Medical Center New York New York
United States Illinois Cancer Specialists (Niles) - USOR Niles Illinois
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Veterans Affairs Pittsburgh Healthcare System Pittsburgh Pennsylvania
United States Northwest Cancer Specialists (Broadway) - USOR Portland Oregon
United States Texas Oncology (Loop) - USOR Round Rock Texas
United States Washington University in St. Louis Saint Louis Missouri
United States Park Nicollet Institute Saint Louis Park Minnesota
United States SCRI Florida Cancer Specialists North Saint Petersburg Florida
United States Texas Oncology (Loop) - USOR San Antonio Texas
United States St Joseph Heritage Healthcare Santa Rosa California
United States George Washington University Washington District of Columbia
United States Yakima Valley Memorial Hospital North Star Lodge - USOR Yakima Washington

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  China,  Colombia,  France,  Germany,  Greece,  Israel,  Italy,  Mexico,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Co-morbidities Baseline up to 8 years
Primary Number of Participants Diagnosed with ND MM and R/R MM Baseline up to 8 years
Primary Number of Participants Presenting Symptoms of ND MM and R/R MM Baseline up to 8 years
Primary Sites of Disease Baseline up to 8 years
Primary ECOG (Eastern Cooperative Oncology Group) Performance Status ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Baseline up to 8 years
Primary Frailty Index Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness. Baseline up to 8 years
Primary Number of Participants Evaluated for Laboratory Test Laboratory tests include minimal residual disease (MRD), gene expression profiling (GEP), fluorescence in situ hybridization (FISH), and cytogenetic results, international staging system (ISS)/R-ISS stage, imaging results. Baseline up to 8 years
Primary Duration for Treatment With Stem Cell Transplant Baseline up to 8 years
Primary Number of Participants Reporting Overall Survival Baseline up to 8 years
Primary Progression Status on Each Regimen Disease progression status was assessed by IMWG Response criteria Baseline up to 8 years
Primary Response to Each Regimen Disease progression status was assessed by IMWG Response criteria Baseline up to 8 years
Primary Time to Next therapy Baseline up to 8 years
Primary Number of Participants With Stem Cell Transplant Baseline up to 8 years
Secondary Number of Treatment Combinations Baseline up to 8 years
Secondary Number of Treatment Sequencing Baseline up to 8 years
Secondary Number of Treatment Rechallenge Baseline up to 8 years
Secondary Number of Clinical Outcomes for Different Strategies Baseline up to 8 years
Secondary Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy Baseline up to 8 years
Secondary Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression Baseline up to 8 years
Secondary Reasons for Treatment Modifications Baseline up to 8 years
Secondary Health Related Quality of Life (HRQoL) Among MM Participants Baseline up to 8 years
Secondary Healthcare Resource Utilization (HRU) Among MM Participants Baseline up to 8 years
Secondary Associations Between Presentation and Disease Characteristics Baseline up to 8 years
Secondary Associations Between Choice Of Therapy and Clinical Outcomes Baseline up to 8 years
Secondary Number of Participants Reporting Discontinuation One or More Treatment-emergent Adverse Events Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies. Baseline up to 8 years
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