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

Multiple Myeloma Clinical Trial

Official title:

A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT - MM Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761187
• Other study ID #: NSMM-5001
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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