Clinical trial NCT02761187: An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants
Official title: A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT - MM Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Myeloma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-05-04
Enrollment: 4253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with Multiple Myeloma

Brief summary: The purpose of this study is to describe contemporary, real-world patterns of participant 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.

Detailed description: This is a prospective, non-interventional, observational study. This study will look at contemporary, real-world patterns of participant 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Co-morbidities
timeFrame: Baseline up to 5 years
measure: Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)
timeFrame: At Baseline
measure: Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study
timeFrame: Baseline up to 5 years
measure: Sites of Disease Diagnosed With ND MM and R/R MM
timeFrame: Baseline up to 5 years
measure: Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status
timeFrame: At Baseline
measure: Number of Participants With Myeloma Frailty Index
timeFrame: At Baseline
measure: Number of Participants Evaluated for Minimal Residual Disease (MRD)
timeFrame: Baseline up to 5 years
measure: Number of Participants Evaluated for Gene Expression Profiling (GEP)
timeFrame: Baseline up to 5 years
measure: Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
timeFrame: At Baseline
measure: Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
timeFrame: At Baseline
measure: Duration of Treatment for Participants With and Without Stem Cell Transplant
timeFrame: Baseline up to 5 years
measure: Overall Survival (OS)
timeFrame: Baseline up to 5 years
measure: Disease Progression Status on Each Regimen
timeFrame: Baseline up to 5 years
measure: Response to Each Regimen
timeFrame: Baseline up to 5 years
measure: Time to Next Therapy
timeFrame: Baseline up to 5 years
measure: Number of Participants With Stem Cell Transplant
timeFrame: Baseline up to 5 years
measure: Number of Participants With Global Health Status Scale/Quality of Life (QoL) Among MM Participants
timeFrame: Baseline up to 5 years
Secondary outcomes:
measure: Number of Participants Receiving Different Treatment Combinations
timeFrame: Baseline up to 5 years
measure: Number of Treatment Sequencing
timeFrame: Baseline up to 5 years
measure: Number of Participants in the Treatment Rechallenge
timeFrame: Baseline up to 5 years
measure: Number of Clinical Outcomes for Different Strategies
timeFrame: Baseline up to 5 years
measure: Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy
timeFrame: Baseline up to 5 years
measure: Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression
timeFrame: Baseline up to 5 years
measure: Reasons for Treatment Modifications
timeFrame: Baseline up to 5 years
measure: Healthcare Resource Utilization (HRU) Among MM Participants
timeFrame: Baseline up to 5 years
measure: Associations Between Presentation and Disease Characteristics
timeFrame: Baseline up to 5 years
measure: Associations Between Choice Of Therapy and Clinical Outcomes
timeFrame: Baseline up to 5 years
measure: Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation
timeFrame: Baseline up to 5 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas For Medical Sciences
state: Arkansas
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers (Williams) - USOR
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Health System
state: Colorado
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Daytona Beach
country: United States
facility: SCRI Florida Cancer Specialists East
state: Florida
city: Fort Myers
country: United States
facility: SCRI Florida Cancer Specialists South
state: Florida
city: Saint Petersburg
country: United States
facility: SCRI Florida Cancer Specialists North
state: Florida
city: Niles
country: United States
facility: Illinois Cancer Specialists (Niles) - USOR
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Lewiston
country: United States
facility: Central Maine Medical Center
state: Maine
city: Columbia
country: United States
facility: Maryland Oncology Hematology (Columbia) - USOR
state: Maryland
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Center
state: Michigan
city: Saint Louis Park
country: United States
facility: Park Nicollet Institute
state: Minnesota
city: Bolivar
country: United States
facility: Central Care Cancer Center
state: Missouri
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Flemington
country: United States
facility: Hunterdon Hematology Oncology
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: East Hills
country: United States
facility: Saint Francis Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Medford
country: United States
facility: Hematology Oncology Associates - USOR
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists (Broadway) - USOR
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Veterans Affairs Pittsburgh Healthcare System
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System Cancer Institute
state: South Carolina
city: Nashville
country: United States
facility: SCRI Tennessee Oncology Nashville
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology (Loop) - USOR
state: Texas
city: Dallas
country: United States
facility: Texas Oncology (Loop) - USOR
state: Texas
city: El Paso
country: United States
facility: Texas Oncology (Loop) - USOR
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Round Rock
country: United States
facility: Texas Oncology (Loop) - USOR
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology (Loop) - USOR
state: Texas
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital North Star Lodge - USOR
state: Washington
city: Martinsburg
country: United States
facility: Berkeley Medical Center
state: West Virginia
city: Green Bay
country: United States
facility: St Vincent Hospital
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Health Care, Aurora Cancer Care
state: Wisconsin
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi asbl
city: Gent
country: Belgium
facility: UZ Gent
city: Haine-Saint-Paul
country: Belgium
facility: Hopital de Jolimont
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU de Liege
city: Yvoir
country: Belgium
facility: CHU UCL Namur asbl - Site Godinne
city: Campinas
country: Brazil
facility: Unicamp Universidade Estadual de Campinas
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas
city: Goiania
country: Brazil
facility: Hospital Das Clinicas Da Universidade Federal de Goias
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal Do Rio de Janeiro Hospital Universitario Clementino Fraga Filho
city: Salvador
country: Brazil
facility: CEHON - Centro de Hematologia e Oncologia da Bahia Ltda
city: Sao Paulo
country: Brazil
facility: Clinica Sao Germano
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University Peoples Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
city: Bogota
country: Colombia
facility: Fundacion Santa Fe de Bogota
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmologica de Santander Foscal
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Monteria
country: Colombia
facility: Oncomedica SA
city: Bayonne
country: France
facility: Centre Hospitalier de La Cote Basque
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Perigueux
country: France
facility: Centre Hospitalier de Perigueux
city: Poitiers
country: France
facility: CHRU de Poitiers La Miletrie
city: Roche-sur-Yon
country: France
facility: Centre Hospitalier Departemental de Vendee
city: Vandoeuvre-les-nancy
country: France
facility: CHU de Nancy-Hopital Brabois Adulte
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dortmund
country: Germany
facility: Gefos - Gesellschaft fur onkologische Studien mbH
city: Heidelberg
country: Germany
facility: Universitatsklinikum Heidelberg
city: Herrsching am Ammersee
country: Germany
facility: Internistisch Hamatologische und Internistische Praxis
city: Koblenz
country: Germany
facility: Institut fur Versorgungsforschung in der Onkologie GbR
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
city: Mannheim
country: Germany
facility: Mannheimer Onkologie Praxis
city: Marburg
country: Germany
facility: OnkoNet Marburg GmbH
city: Siegburg
country: Germany
facility: Onkologische Gemeinschaftspraxis Siegburg
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Alexandroupoli
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
city: Athens
country: Greece
facility: Alexandra Hospital
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Larisa
country: Greece
facility: University General Hospital of Larissa
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kefar-Sava
country: Israel
facility: Meir Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Medical Centers
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Roma
country: Italy
facility: Azienda Policlinico Umberto I
city: Torino
country: Italy
facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Udine
city: Guadalajara
country: Mexico
facility: Nucleo Oncologico de Occidente S.C.
city: Huixquilucan
country: Mexico
facility: Hematologica Alta Especialidad S.C.
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Puzi
country: Taiwan
facility: Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
state: Chiayi County
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Adana
country: Turkey
facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty Cebeci Hospital
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Gebze
country: Turkey
facility: Johns Hopkins Medicine - Anadolu Saglik Merkezi
city: Istanbul
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Faculty of Medicine
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital - PPDS
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Wakefield
country: United Kingdom
facility: Pinderfields General Hospital
Study officials:
References:
citation: 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.
citation: 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.