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

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Myeloma
• Intervention / Treatment: Other: No Intervention

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.

• Study Type: Observational
• Enrollment (Actual): 4253

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants with Multiple Myeloma

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: No Intervention; As this was an observational study, no intervention was administered.
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).	Other: No Intervention; As this was an observational study, no intervention was administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Receiving Different Treatment Combinations		Baseline up to 5 years
Number of Treatment Sequencing	Drug classes were based on the earliest regimen in each corresponding Line of Therapy. The data for this outcome measure was analyzed as per line of therapy.	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
Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression		Baseline up to 5 years
Reasons for Treatment Modifications		Baseline up to 5 years
Healthcare Resource Utilization (HRU) Among MM Participants		Baseline up to 5 years
Associations Between Presentation and Disease Characteristics		Baseline up to 5 years
Associations Between Choice Of Therapy and Clinical Outcomes		Baseline up to 5 years
Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.	Baseline up to 5 years

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimated): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: NSMM-5001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No