이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2022년 2월 15일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (실제)

4310

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

Participants with Multiple Myeloma

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Relapsed/refractory (R/R) MM
Patients who have received 1 to 3 prior lines of therapy
다른: 간섭 없음
Newly diagnosed (ND) MM
Patients within 3 months from initiation of treatment
다른: 간섭 없음

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants with Co-morbidities
기간: Baseline up to 8 years
Baseline up to 8 years
Number of Participants Diagnosed with ND MM and R/R MM
기간: Baseline up to 8 years
Baseline up to 8 years
Number of Participants Presenting Symptoms of ND MM and R/R MM
기간: Baseline up to 8 years
Baseline up to 8 years
Sites of Disease
기간: Baseline up to 8 years
Baseline up to 8 years
ECOG (Eastern Cooperative Oncology Group) Performance Status
기간: 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
기간: 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
기간: 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
기간: Baseline up to 8 years
Baseline up to 8 years
Number of Participants Reporting Overall Survival
기간: Baseline up to 8 years
Baseline up to 8 years
Progression Status on Each Regimen
기간: Baseline up to 8 years
Disease progression status was assessed by IMWG Response criteria
Baseline up to 8 years
Response to Each Regimen
기간: Baseline up to 8 years
Disease progression status was assessed by IMWG Response criteria
Baseline up to 8 years
Time to Next therapy
기간: Baseline up to 8 years
Baseline up to 8 years
Number of Participants With Stem Cell Transplant
기간: Baseline up to 8 years
Baseline up to 8 years

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Takeda

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 7월 1일

기본 완료 (실제)

2021년 9월 30일

연구 완료 (실제)

2021년 9월 30일

연구 등록 날짜

최초 제출

2016년 4월 28일

QC 기준을 충족하는 최초 제출

2016년 5월 2일

처음 게시됨 (추정)

2016년 5월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 2월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 2월 15일

마지막으로 확인됨

2022년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NSMM-5001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

다발성 골수종에 대한 임상 시험

간섭 없음에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Nigeria

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다