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

15 de febrero de 2022 actualizado por: Takeda

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

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

4310

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Chemnitz, Alemania
        • Klinikum Chemnitz gGMbH
      • Dortmund, Alemania
        • Gefos - Gesellschaft fur onkologische Studien mbH
      • Heidelberg, Alemania
        • Universitätsklinikum Heidelberg
      • Herrsching am Ammersee, Alemania
        • Internistisch Hamatologische und Internistische Praxis
      • Koblenz, Alemania
        • Institut fur Versorgungsforschung in der Onkologie GbR
      • Mainz, Alemania
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Mannheim, Alemania
        • Mannheimer Onkologie Praxis
      • Marburg, Alemania
        • OnkoNet Marburg GmbH
      • Siegburg, Alemania
        • Onkologische Gemeinschaftspraxis Siegburg
      • Tubingen, Alemania
        • Universitätsklinikum Tübingen
  • Brasil
      • Campinas, Brasil, 13083-970
        • Unicamp Universidade Estadual de Campinas
      • Florianopolis, Brasil, 88034
        • Centro de Pesquisas Oncologicas
      • Goiania, Brasil, 74680-160
        • Hospital das Clínicas da Universidade Federal de Goiás
      • Rio de Janeiro, Brasil, 21941-913
        • Universidade Federal Do Rio de Janeiro Hospital Universitario Clementino Fraga Filho
      • Salvador, Brasil, 40110-090
        • CEHON - Centro de Hematologia e Oncologia da Bahia Ltda
      • Sao Paulo, Brasil, 05651-901
        • Hospital Israelita Albert Einstein
      • Sao Paulo, Brasil, 5403000
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
      • Sao Paulo, Brasil, 04537-081
        • Clinica Sao Germano
  • Bélgica
      • Charleroi, Bélgica, 6000
        • Grand Hopital de Charleroi asbl
      • Gent, Bélgica, 9000
        • UZ Gent
      • Haine-Saint-Paul, Bélgica, 7100
        • Hôpital de Jolimont
      • Leuven, Bélgica, 3000
        • UZ Leuven
      • Liege, Bélgica, 4000
        • CHU de Liège
      • Yvoir, Bélgica, 5530
        • CHU UCl Namur asbl - Site Godinne
  • Colombia
      • Bogota, Colombia
        • Fundacion Santa Fe de Bogota
      • Floridablanca, Colombia
        • Fundación Oftalmológica de Santander FOSCAL
      • Medellin, Colombia
        • Hospital Pablo Tobon Uribe
      • Monteria, Colombia
        • Oncomedica SA
  • España
      • Barcelona, España, 8036
        • Hospital Clínic de Barcelona
      • Granada, España, 18014
        • Hospital Universitario Virgen de las Nieves
      • Leon, España, 24080
        • Complejo Asistencial Universitario de León
      • Madrid, España, 28041
        • Hospital Universitario 12 de octubre
      • Salamanca, España, 37007
        • Hospital Universitario de Salamanca
      • Valencia, España
        • Hospital Universitari i Politecnic La Fe de Valencia
  • Estados Unidos
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Estados Unidos, 72205
        • CARTI Cancer Center
    • California
      • La Jolla, California, Estados Unidos, 92093
        • University of California San Diego
      • Santa Rosa, California, Estados Unidos, 95403
        • St Joseph Heritage Healthcare
    • Colorado
      • Denver, Colorado, Estados Unidos, 80218
        • Rocky Mountain Cancer Centers (Williams) - USOR
      • Fort Collins, Colorado, Estados Unidos, 80528
        • Poudre Valley Health System
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20037
        • George Washington University
    • Florida
      • Daytona Beach, Florida, Estados Unidos, 32117
        • SCRI Florida Cancer Specialists East
      • Fort Myers, Florida, Estados Unidos, 33916
        • SCRI Florida Cancer Specialists South
      • Saint Petersburg, Florida, Estados Unidos, 33705
        • Scri Florida Cancer Specialists North
    • Illinois
      • Niles, Illinois, Estados Unidos, 60714
        • Illinois Cancer Specialists (Niles) - USOR
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Indiana University
    • Louisiana
      • Metairie, Louisiana, Estados Unidos, 70006
        • East Jefferson General Hospital
    • Maine
      • Lewiston, Maine, Estados Unidos, 04240
        • Central Maine Medical Center
    • Maryland
      • Columbia, Maryland, Estados Unidos, 21044
        • Maryland Oncology Hematology (Columbia) - USOR
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Barbara Ann Karmanos Cancer Center
    • Minnesota
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • Park Nicollet Institute
    • Missouri
      • Bolivar, Missouri, Estados Unidos, 65613
        • Central Care Cancer Center
      • Kansas City, Missouri, Estados Unidos, 64128
        • Kansas City VA Medical Center
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Washington University in St. Louis
    • New Jersey
      • Flemington, New Jersey, Estados Unidos, 08822
        • Hunterdon Hematology Oncology
    • New Mexico
      • Farmington, New Mexico, Estados Unidos, 87401
        • San Juan Oncology Associates
    • New York
      • East Hills, New York, Estados Unidos, 11576
        • Saint Francis Hospital
      • New York, New York, Estados Unidos, 10029
        • Mount Sinai Medical Center
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28402
        • Levine Cancer Center
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45220
        • University of Cincinnati
    • Oregon
      • Medford, Oregon, Estados Unidos, 97504
        • Hematology Oncology Associates - USOR
      • Portland, Oregon, Estados Unidos, 97227
        • Northwest Cancer Specialists (Broadway) - USOR
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, Estados Unidos, 15240
        • Veterans Affairs Pittsburgh Healthcare System
    • South Carolina
      • Greenville, South Carolina, Estados Unidos, 29615
        • Greenville Health System Cancer Institute
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • SCRI Tennessee Oncology Nashville
    • Texas
      • Amarillo, Texas, Estados Unidos, 79106
        • Texas Oncology (LOOP) - USOR
      • Dallas, Texas, Estados Unidos, 92056
        • Texas Oncology (LOOP) - USOR
      • El Paso, Texas, Estados Unidos, 79902
        • Texas Oncology (LOOP) - USOR
      • Houston, Texas, Estados Unidos, 77030
        • University of Texas MD Anderson Cancer Center
      • Round Rock, Texas, Estados Unidos, 78681
        • Texas Oncology (LOOP) - USOR
      • San Antonio, Texas, Estados Unidos, 78217
        • Texas Oncology (LOOP) - USOR
    • Washington
      • Yakima, Washington, Estados Unidos, 98902
        • Yakima Valley Memorial Hospital North Star Lodge - USOR
    • West Virginia
      • Martinsburg, West Virginia, Estados Unidos, 25401
        • Berkeley Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, Estados Unidos, 54307
        • St Vincent Hospital
      • Madison, Wisconsin, Estados Unidos, 53792
        • University of Wisconsin Carbone Cancer Center
      • Milwaukee, Wisconsin, Estados Unidos, 53215
        • Aurora Health Care, Aurora Cancer Care
  • Francia
      • Bayonne, Francia, 64109
        • Centre Hospitalier de la Côte Basque
      • Le Mans, Francia, 72000
        • Centre Hospitalier Le Mans
      • Perigueux, Francia, 24019
        • Centre Hospitalier de Périgueux
      • Poitiers, Francia, 86021
        • CHRU de Poitiers La Miletrie
      • Roche-sur-Yon, Francia, 85000
        • Centre Hospitalier Departemental de Vendee
      • Vandoeuvre-les-nancy, Francia, 54211
        • CHU de Nancy-Hopital Brabois Adulte
  • Grecia
      • Alexandroupoli, Grecia, 68100
        • University Hospital of Alexandroupolis
      • Athens, Grecia, 10676
        • Evangelismos General Hospital of Athens
      • Athens, Grecia, 11525
        • Alexandra Hospital
      • Ioannina, Grecia, 45500
        • University General Hospital of Ioannina
      • Larisa, Grecia, 41110
        • University General Hospital of Larissa
      • Patras, Grecia, 26500
        • University General Hospital of Patras
  • Israel
      • Afula, Israel, 18371
        • HaEmek Medical Center
      • Haifa, Israel, 34362
        • Lady Davis Carmel Medical Center
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
      • Kefar-Sava, Israel, 44281
        • Meir Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
      • Tel Aviv, Israel, 69710
        • Assuta Medical Centers
  • Italia
      • Ancona, Italia, 60020
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
      • Bologna, Italia, 40138
        • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
      • Catania, Italia
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
      • Firenze, Italia, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Napoli, Italia
        • Azienda Ospedaliera Universitaria Federico II
      • Roma, Italia, 00161
        • Azienda Policlinico Umberto I
      • Torino, Italia
        • Azienda Ospedaliera Citta della Salute e della Scienza di Torino
      • Udine, Italia, 33100
        • Azienda Sanitaria Universitaria Integrata di Udine
  • México
      • Guadalajara, México, 44670
        • Nucleo Oncologico de Occidente S.C.
      • Huixquilucan, México
        • Hematologica Alta Especialidad S.C.
      • Mexico City, México, 14000
        • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
      • Monterrey, México, 64460
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Pavo
      • Adana, Pavo
        • Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
      • Ankara, Pavo
        • Ankara University Medical Faculty Cebeci Hospital
      • Antalya, Pavo
        • Akdeniz University Medical Faculty
      • Gebze, Pavo
        • Johns Hopkins Medicine - Anadolu Saglik Merkezi
      • Istanbul, Pavo
        • Ege Universitesi Tip Fakultesi Hastanesi
      • Istanbul, Pavo
        • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
      • Izmir, Pavo
        • Dokuz Eylul University Medical Faculty
      • Kayseri, Pavo
        • Erciyes Universitesi Tip Fakultesi Hastanesi
      • Samsun, Pavo
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
      • Trabzon, Pavo
        • Karadeniz Technical University Faculty of Medicine
  • Porcelana
      • Beijing, Porcelana, 100730
        • Peking Union Medical College Hospital
      • Beijing, Porcelana
        • Peking University Peoples Hospital
      • Hangzhou, Porcelana, 310003
        • The First Affiliated Hospital of College of Medicine, Zhejiang University
      • Suzhou, Porcelana, 215006
        • First Affiliated Hospital of Soochow University
  • Reino Unido
      • Bath, Reino Unido
        • Royal United Hospital
      • Birmingham, Reino Unido, B9 5SS
        • Birmingham Heartlands Hospital
      • Birmingham, Reino Unido, B15 2TH
        • University Hospital Birmingham
      • Bournemouth, Reino Unido, BH7 7DW
        • Royal Bournemouth Hospital
      • Dundee, Reino Unido, DD1 9SY
        • Ninewells Hospital - PPDS
      • Leicester, Reino Unido, LE1 5WW
        • Leicester Royal Infirmary
      • Nottingham, Reino Unido, NG5 1PB
        • Nottingham University Hospitals NHS Trust
      • Sutton, Reino Unido, SM2 5PT
        • The Royal Marsden NHS Foundation Trust
      • Wakefield, Reino Unido, WF1 4DG
        • Pinderfields General Hospital
    • West Yorkshire
      • Leeds, West Yorkshire, Reino Unido, LS1 3EX
        • Leeds Teaching Hospitals NHS Trust
  • Taiwán
      • Kaohsiung, Taiwán, 807
        • Kaohsiung Medical University Hospital
      • Kaohsiung, Taiwán
        • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
      • Taichung City, Taiwán, 40447
        • China Medical University Hospital
      • Tainan, Taiwán, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwán, 10002
        • National Taiwan University Hospital
    • Chiayi County
      • Puzi, Chiayi County, Taiwán, 613
        • Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Participants with Multiple Myeloma

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Relapsed/refractory (R/R) MM
Patients who have received 1 to 3 prior lines of therapy
Otro: Sin intervención
Newly diagnosed (ND) MM
Patients within 3 months from initiation of treatment
Otro: Sin intervención

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants with Co-morbidities
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Number of Participants Diagnosed with ND MM and R/R MM
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Number of Participants Presenting Symptoms of ND MM and R/R MM
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Sites of Disease
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
ECOG (Eastern Cooperative Oncology Group) Performance Status
Periodo de tiempo: Baseline up to 8 years
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
Frailty Index
Periodo de tiempo: Baseline up to 8 years
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
Number of Participants Evaluated for Laboratory Test
Periodo de tiempo: Baseline up to 8 years
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
Duration for Treatment With Stem Cell Transplant
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Number of Participants Reporting Overall Survival
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Progression Status on Each Regimen
Periodo de tiempo: Baseline up to 8 years
Disease progression status was assessed by IMWG Response criteria
Baseline up to 8 years
Response to Each Regimen
Periodo de tiempo: Baseline up to 8 years
Disease progression status was assessed by IMWG Response criteria
Baseline up to 8 years
Time to Next therapy
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Number of Participants With Stem Cell Transplant
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Treatment Combinations
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Number of Treatment Sequencing
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Number of Treatment Rechallenge
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Number of Clinical Outcomes for Different Strategies
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Reasons for Treatment Modifications
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Health Related Quality of Life (HRQoL) Among MM Participants
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Healthcare Resource Utilization (HRU) Among MM Participants
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Associations Between Presentation and Disease Characteristics
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Associations Between Choice Of Therapy and Clinical Outcomes
Periodo de tiempo: Baseline up to 8 years
Baseline up to 8 years
Number of Participants Reporting Discontinuation One or More Treatment-emergent Adverse Events
Periodo de tiempo: Baseline up to 8 years
Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.
Baseline up to 8 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Takeda

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de julio de 2016

Finalización primaria (Actual)

30 de septiembre de 2021

Finalización del estudio (Actual)

30 de septiembre de 2021

Fechas de registro del estudio

Enviado por primera vez

28 de abril de 2016

Primero enviado que cumplió con los criterios de control de calidad

2 de mayo de 2016

Publicado por primera vez (Estimar)

4 de mayo de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de febrero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

15 de febrero de 2022

Última verificación

1 de febrero de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NSMM-5001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Criterios de acceso compartido de IPD

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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