Study Stopped
This study was stopped 3 years early due to business reprioritization within Takeda
An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants
A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT - MM Study
1 other identifier
observational
4,253
15 countries
137
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2016
Longer than P75 for all trials
137 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2016
CompletedFirst Posted
Study publicly available on registry
May 4, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedResults Posted
Study results publicly available
February 24, 2025
CompletedFebruary 24, 2025
January 1, 2025
5.3 years
April 28, 2016
September 30, 2022
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (17)
Number of Participants With Co-morbidities
Charlson Comorbidity Index (CCI) was used to represent number of participants with co-morbidities. CCI is a method of categorizing comorbidities of participants. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a participant. A score of 0 = no comorbidities found, 1 = not ill, 2 = mildly ill, 3 = moderately ill, 4 = severely ill, and ≥5 = moribund. The higher the score, the more likely the predicted outcome resulted in mortality or higher resource use.
Baseline up to 5 years
Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)
Participants diagnosed with NDMM and R/RMM were determined at the start of the study.
At Baseline
Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study
Baseline up to 5 years
Sites of Disease Diagnosed With ND MM and R/R MM
Baseline up to 5 years
Number of Participants With 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 6 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 hours), 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 hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The line of Therapy was determined at study entry.
At Baseline
Number of Participants With Myeloma Frailty Index
Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness. The Myeloma Frailty Index is a composite index that was calculated using the points system, which produces a range of values from 0 to 5. Participants with score 0= fit, score 1= intermediate, and score ≥2= frail. Higher score indicates likeliness that the predicted outcome will result in frailty. The line of Therapy was determined at study entry.
At Baseline
Number of Participants Evaluated for Minimal Residual Disease (MRD)
Baseline up to 5 years
Number of Participants Evaluated for Gene Expression Profiling (GEP)
Baseline up to 5 years
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
FISH methodology was reported with Yes/No results for the following tests: deletion (17p)/p53 \[Del(17p)/p53\], translocation (4,14) \[t(4,14)\], and translocation (14,16) \[t(14,16)\].
At Baseline
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
ISS disease stages were defined as I:low risk, β2-Microglobulin\<3.5mg/L, albumin≥3.5g/dL, II:not stage I or III, III:high risk,β2-Microglobulin≥5.5mg/L). R-ISS is based on ISS, chromosomal abnormalities (CA), and lactate dehydrogenase (LDH). R-ISS disease stages were defined as I: ISS Stage I and standard risk CA by FISH and normal LDH (i.e. \<=300 U/L), II: Neither R-ISS Stage I nor Stage III, III: ISS Stage III and either high risk CA by FISH or high LDH (i.e. \>300 U/L).
At Baseline
Duration of Treatment for Participants With and Without Stem Cell Transplant
Data was analyzed for participants with and without stem cell transplant for all enrolled population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data.
Baseline up to 5 years
Overall Survival (OS)
Overall Survival was defined as the number of months from the index regimen start date within each line of therapy, starting with the line during study entry, until the date of death. The Kaplan Meier estimates was used for the analysis.
Baseline up to 5 years
Disease Progression Status on Each Regimen
Disease progression status was assessed by physician interpretation of IMWG Response criteria.
Baseline up to 5 years
Response to Each Regimen
Baseline up to 5 years
Time to Next Therapy
The line of Therapy was determined at study entry. The Kaplan Meier estimates was used for the analysis.
Baseline up to 5 years
Number of Participants With Stem Cell Transplant
Baseline up to 5 years
Number of Participants With Global Health Status Scale/Quality of Life (QoL) Among MM Participants
The Global Health Status scale/QoL scale included 2 questions measured with a 7-point numeric rating scale (very poor to excellent). Raw scores are converted into scale scores ranging from 0 to 100. A higher score represents better HRQoL.
Baseline up to 5 years
Secondary Outcomes (11)
Number of Participants Receiving Different Treatment Combinations
Baseline up to 5 years
Number of Treatment Sequencing
Baseline up to 5 years
Number of Participants in the Treatment Rechallenge
Baseline up to 5 years
Number of Clinical Outcomes for Different Strategies
Baseline up to 5 years
Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy
Baseline up to 5 years
- +6 more secondary outcomes
Study Arms (2)
Newly Diagnosed Multiple Myeloma
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
Relapsed/Refractory Multiple Myeloma
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
Interventions
As this was an observational study, no intervention was administered.
Eligibility Criteria
Participants with Multiple Myeloma
You may qualify if:
- Is 18 years of age or older.
- Is experiencing the following:
- 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
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (137)
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
University of Arkansas For Medical Sciences
Little Rock, Arkansas, 72205, United States
University of California San Diego
La Jolla, California, 92093, United States
St Joseph Heritage Healthcare
Santa Rosa, California, 95403, United States
Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado, 80218, United States
Poudre Valley Health System
Fort Collins, Colorado, 80528, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
SCRI Florida Cancer Specialists East
Daytona Beach, Florida, 32117, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, 33916, United States
SCRI Florida Cancer Specialists North
St. Petersburg, Florida, 33705, United States
Illinois Cancer Specialists (Niles) - USOR
Niles, Illinois, 60714, United States
Indiana University
Indianapolis, Indiana, 46202, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
Central Maine Medical Center
Lewiston, Maine, 04240, United States
Maryland Oncology Hematology (Columbia) - USOR
Columbia, Maryland, 21044, United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, 55416, United States
Central Care Cancer Center
Bolivar, Missouri, 65613, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Hunterdon Hematology Oncology
Flemington, New Jersey, 08822, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Saint Francis Hospital
East Hills, New York, 11576, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Levine Cancer Center
Charlotte, North Carolina, 28402, United States
University of Cincinnati
Cincinnati, Ohio, 45220, United States
Hematology Oncology Associates - USOR
Medford, Oregon, 97504, United States
Northwest Cancer Specialists (Broadway) - USOR
Portland, Oregon, 97227, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Veterans Affairs Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Greenville Health System Cancer Institute
Greenville, South Carolina, 29615, United States
SCRI Tennessee Oncology Nashville
Nashville, Tennessee, 37203, United States
Texas Oncology (Loop) - USOR
Amarillo, Texas, 79106, United States
Texas Oncology (Loop) - USOR
Dallas, Texas, 92056, United States
Texas Oncology (Loop) - USOR
El Paso, Texas, 79902, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology (Loop) - USOR
Round Rock, Texas, 78681, United States
Texas Oncology (Loop) - USOR
San Antonio, Texas, 78217, United States
Yakima Valley Memorial Hospital North Star Lodge - USOR
Yakima, Washington, 98902, United States
Berkeley Medical Center
Martinsburg, West Virginia, 25401, United States
St Vincent Hospital
Green Bay, Wisconsin, 54307, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Aurora Health Care, Aurora Cancer Care
Milwaukee, Wisconsin, 53215, United States
Grand Hopital de Charleroi asbl
Charleroi, 6000, Belgium
UZ Gent
Ghent, 9000, Belgium
Hopital de Jolimont
Haine-Saint-Paul, 7100, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU de Liege
Liège, 4000, Belgium
CHU UCL Namur asbl - Site Godinne
Yvoir, 5530, Belgium
Unicamp Universidade Estadual de Campinas
Campinas, 13083-970, Brazil
Centro de Pesquisas Oncologicas
Florianópolis, 88034, Brazil
Hospital Das Clinicas Da Universidade Federal de Goias
Goiânia, 74680-160, Brazil
Universidade Federal Do Rio de Janeiro Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, 21941-913, Brazil
CEHON - Centro de Hematologia e Oncologia da Bahia Ltda
Salvador, 40110-090, Brazil
Clinica Sao Germano
São Paulo, 04537-081, Brazil
Hospital Israelita Albert Einstein
São Paulo, 05651-901, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 5403000, Brazil
Peking Union Medical College Hospital
Beijing, 100730, China
Peking University Peoples Hospital
Beijing, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, 310003, China
First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Fundacion Santa Fe de Bogota
Bogotá, Colombia
Fundacion Oftalmologica de Santander Foscal
Floridablanca, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia
Oncomedica SA
Montería, Colombia
Centre Hospitalier de La Cote Basque
Bayonne, 64109, France
Centre Hospitalier Departemental de Vendee
La Roche-sur-Yon, 85000, France
Centre Hospitalier Le Mans
Le Mans, 72000, France
Centre Hospitalier de Perigueux
Périgueux, 24019, France
CHRU de Poitiers La Miletrie
Poitiers, 86021, France
CHU de Nancy-Hopital Brabois Adulte
Vandœuvre-lès-Nancy, 54211, France
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
Tübingen, Germany
University Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
Evangelismos General Hospital of Athens
Athens, 10676, Greece
Alexandra Hospital
Athens, 11525, Greece
University General Hospital of Ioannina
Ioannina, 45500, Greece
University General Hospital of Larissa
Larissa, 41110, Greece
University General Hospital of Patras
Pátrai, 26500, Greece
HaEmek Medical Center
Afula, 18371, Israel
Lady Davis Carmel Medical Center
Haifa, 34362, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Meir Medical Center
Kefar Sava, 44281, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Assuta Medical Centers
Tel Aviv, 69710, Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona, 60020, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Italy
Azienda Policlinico Umberto I
Roma, 00161, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, Italy
Azienda Sanitaria Universitaria Integrata di Udine
Udine, 33100, Italy
Nucleo Oncologico de Occidente S.C.
Guadalajara, 44670, Mexico
Hematologica Alta Especialidad S.C.
Huixquilucan, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14000, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Hospital Clinic de Barcelona
Barcelona, 8036, Spain
Hospital Universitario Virgen de Las Nieves
Granada, 18014, Spain
Complejo Asistencial Universitario de Leon
León, 24080, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain
Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
Buzi, Chiayi County, 613, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
Adana, Turkey (Türkiye)
Ankara University Medical Faculty Cebeci Hospital
Ankara, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, Turkey (Türkiye)
Johns Hopkins Medicine - Anadolu Saglik Merkezi
Gebze, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Istanbul, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, Turkey (Türkiye)
Karadeniz Technical University Faculty of Medicine
Trabzon, Turkey (Türkiye)
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS1 3EX, United Kingdom
Royal United Hospital
Bath, United Kingdom
University Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Bh7 7dw, United Kingdom
Ninewells Hospital - PPDS
Dundee, DD1 9SY, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
Pinderfields General Hospital
Wakefield, WF1 4DG, United Kingdom
Related Publications (5)
Puig N, Leleu X, Lee HC, Davies FE, Hajek R, Hungria V, Thompson MA, Cook G, Ojeda JV, Weisel KC, Berdeja JG, Usmani SZ, Symeonidis A, Nascimento-Ferreira I, Arthur D, Mokra L, Ren K, Cherepanov D, Terpos E. Comparative Effectiveness and Safety of PI-Rd Triplets in Relapsed/Refractory Multiple Myeloma: INSIGHT-MM Data Analysis. Eur J Haematol. 2026 Jan 13. doi: 10.1111/ejh.70079. Online ahead of print.
PMID: 41528195DERIVEDRifkin RM, Costello CL, Birhiray RE, Kambhampati S, Richter J, Abonour R, Lee HC, Stokes M, Ren K, Stull DM, Cherepanov D, Bogard K, Noga SJ, Girnius S. In-class transition from bortezomib-based therapy to IRd is an effective approach in newly diagnosed multiple myeloma. Future Oncol. 2024 Jan;20(3):131-143. doi: 10.2217/fon-2023-0272. Epub 2023 Oct 9.
PMID: 37807952DERIVEDThompson MA, Boccadoro M, Leleu X, Vela-Ojeda J, van Rhee F, Weisel KC, Rifkin RM, Usmani SZ, Hajek R, Cook G, Abonour R, Armour M, Morgan KE, Yeh SP, Costello CL, Berdeja JG, Davies FE, Zonder JA, Lee HC, Omel J, Spencer A, Terpos E, Hungria VTM, Puig N, Fu C, Ferrari RH, Ren K, Stull DM, Chari A. Rates of Influenza and Pneumococcal Vaccination and Correlation With Survival in Multiple Myeloma Patients. Clin Lymphoma Myeloma Leuk. 2023 Mar;23(3):e171-e181. doi: 10.1016/j.clml.2022.12.003. Epub 2022 Dec 7.
PMID: 36641358DERIVEDHajek 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.
PMID: 33769076DERIVEDCostello 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.
PMID: 30816809DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated 3 years early due to business reprioritization within Takeda.
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2016
First Posted
May 4, 2016
Study Start
July 1, 2016
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
February 24, 2025
Results First Posted
February 24, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- 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.
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.