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

This study is currently recruiting participants.
Verified October 2017 by Takeda
Sponsor:
ClinicalTrials.gov Identifier:
NCT02761187
First Posted: May 4, 2016
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
The purpose of this study is to describe contemporary, real-world disease and participant presentation, therapies, and clinical outcomes in both participants with newly diagnosed and not yet relapsed [ND] multiple myeloma (MM), and participants with relapsed/refractory [R/R] MM.

Condition Intervention
Multiple Myeloma Other: No Intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT-MM Study

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Number of Participants with Co-morbidities [ Time Frame: Baseline up to 5 years ]
  • Number of Participants Diagnosed with ND MM and R/R MM [ Time Frame: Baseline up to 5 years ]
  • Number of Participants Presenting Symptoms of ND MM and R/R MM [ Time Frame: Baseline up to 5 years ]
  • Sites of Disease [ Time Frame: Baseline up to 5 years ]
  • ECOG (Eastern Cooperative Oncology Group) Performance Status [ Time Frame: Baseline up to 5 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.

  • Frailty Index [ Time Frame: Baseline up to 5 years ]
    Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.

  • Number of Participants Evaluated for Laboratory Test [ Time Frame: Baseline up to 5 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.

  • Number of Participants With Stem Cell Transplant [ Time Frame: Baseline up to 5 years ]
  • Number of Participants With Stem Cell Transplant Treatment [ Time Frame: Baseline up to 5 years ]
  • Duration for Treatment With Stem Cell Transplant [ Time Frame: Baseline up to 5 years ]
  • Number of Participants Reporting Overall Survival [ Time Frame: Baseline up to 5 years ]
  • Progression Status on Each Regimen [ Time Frame: Baseline up to 5 years ]
  • Response to Each Regimen [ Time Frame: Baseline up to 5 years ]
  • Time to Next therapy [ Time Frame: Baseline up to 5 years ]

Secondary Outcome Measures:
  • Number of Treatment Combinations [ Time Frame: Baseline up to 5 years ]
  • Number of Treatment Sequencing [ Time Frame: Baseline up to 5 years ]
  • Number of Treatment Rechallenge [ Time Frame: Baseline up to 5 years ]
  • Number of Clinical Outcomes for Different Strategies [ Time Frame: Baseline up to 5 years ]
  • Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy [ Time Frame: Baseline up to 5 years ]
  • Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression [ Time Frame: Baseline up to 5 years ]
  • Reasons for Treatment Modifications [ Time Frame: Baseline up to 5 years ]
  • Health Related Quality of Life (HRQoL) Among MM Participants [ Time Frame: Baseline up to 5 years ]
  • Healthcare Resource Utilization (HRU) Among MM Participants [ Time Frame: Baseline up to 5 years ]
  • Associations Between Presentation and Disease Characteristics [ Time Frame: Baseline up to 5 years ]
  • Associations Between Choice Of Therapy and Clinical Outcomes [ Time Frame: Baseline up to 5 years ]
  • Number of Participants Reporting Discontinuation One or More Treatment-emergent Adverse Events [ Time Frame: Baseline up to 5 years ]
    Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.


Estimated Enrollment: 5000
Actual Study Start Date: July 1, 2016
Estimated Study Completion Date: July 31, 2024
Estimated Primary Completion Date: July 31, 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Relapsed/refractory (R/R) MM Other: No Intervention
Newly diagnosed (ND) multiple myeloma (MM) Other: No Intervention

Detailed Description:

This is a non-interventional, observational. This study will look at contemporary, real-world presentation, therapies, and clinical outcomes in participants with MM. Participants will not be asked to change their routine clinical treatment. Participants will have to complete a patient self-reported outcomes (PROs) survey at home or during routine visits.

The study will enroll approximately 5000 participants. Participants will be assigned to one of the following cohorts based upon the diagnosis of MM:

  • ND MM
  • R/R MM

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 5 years. Participants will be evaluated and followed-up for a period of at least 5 years, until death, or the end of the study, whichever comes first.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with Multiple Myeloma
Criteria

Inclusion Criteria:

Is 18 years of age or older. Is newly diagnosed and not yet relapsed MM with documented month and year of diagnosis, criteria met for diagnosis, stage, and MM-directed treatment history, including duration, or Has relapsed/refractory MM with documented data in the medical record regarding diagnosis (month and year), prior exposure to classes of medications (example, proteosome inhibitors, immunomodulatory drugs), and number of previous lines of therapies.

Is willing and able to sign informed consent to participate. Is willing and able to complete patient assessment questionnaires.

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.

Is unable or unwilling to complete health related quality of life (HRQoL) and Patient self-reported outcomes (PROs).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761187


Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

  Hide Study Locations
Locations
United States, Arkansas
CARTI Cancer Center Recruiting
Little Rock, Arkansas, United States, 72205
University of Arkansas For Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
St Joseph Heritage Healthcare Recruiting
Santa Rosa, California, United States, 95403
United States, Colorado
Rocky Mountain Cancer Centers (Williams) - USOR Recruiting
Denver, Colorado, United States, 80218
Poudre Valley Health System Recruiting
Fort Collins, Colorado, United States, 80528
United States, District of Columbia
George Washington University Recruiting
Washington, D.C., District of Columbia, United States, 20037
United States, Florida
SCRI Florida Cancer Specialists East Recruiting
Daytona Beach, Florida, United States, 32117
SCRI Florida Cancer Specialists South Recruiting
Fort Myers, Florida, United States, 33916
SCRI Florida Cancer Specialists North Recruiting
Saint Petersburg, Florida, United States, 33705
United States, Illinois
Illinois Cancer Specialists (Niles) - USOR Recruiting
Niles, Illinois, United States, 60714
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
United States, Louisiana
East Jefferson General Hospital Recruiting
Metairie, Louisiana, United States, 70006
United States, Maine
Central Maine Medical Center Recruiting
Lewiston, Maine, United States, 4240
United States, Maryland
Maryland Oncology Hematology (Columbia) - USOR Recruiting
Columbia, Maryland, United States, 21044
United States, Michigan
Barbara Ann Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Park Nicollet Institute Recruiting
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Central Care Cancer Center Recruiting
Bolivar, Missouri, United States, 65613
Kansas City VA Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hunterdon Hematology Oncology Recruiting
Flemington, New Jersey, United States, 8822
United States, New Mexico
San Juan Oncology Associates Recruiting
Farmington, New Mexico, United States, 87401
United States, New York
Saint Francis Hospital Recruiting
East Hills, New York, United States, 11576
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
United States, North Carolina
Levine Cancer Center Recruiting
Charlotte, North Carolina, United States, 28402
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45220
United States, Oregon
Hematology Oncology Associates - USOR Recruiting
Medford, Oregon, United States, 97504
Northwest Cancer Specialists (Broadway) - USOR Recruiting
Portland, Oregon, United States, 97227
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2434
United States, South Carolina
Greenville Health System Cancer Institute Recruiting
Greenville, South Carolina, United States, 29615
United States, Tennessee
SCRI Tennessee Oncology Nashville Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology (Loop) - USOR Recruiting
Amarillo, Texas, United States, 79106
Texas Oncology (Loop) - USOR Recruiting
Dallas, Texas, United States, 92056
Texas Oncology (Loop) - USOR Recruiting
El Paso, Texas, United States, 79902
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Texas Oncology (Loop) - USOR Recruiting
Round Rock, Texas, United States, 78681
Texas Oncology (Loop) - USOR Recruiting
San Antonio, Texas, United States, 78217
United States, Washington
Yakima Valley Memorial Hospital North Star Lodge - USOR Recruiting
Yakima, Washington, United States, 98902
United States, West Virginia
Berkeley Medical Center Recruiting
Martinsburg, West Virginia, United States, 25401
United States, Wisconsin
St Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54307
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Aurora Health Care, Aurora Cancer Care Recruiting
Milwaukee, Wisconsin, United States, 53215
Belgium
Grand Hopital de Charleroi asbl Recruiting
Charleroi, Belgium, 6000
UZ Gent Recruiting
Gent, Belgium, 9000
Hopital de Jolimont Recruiting
Haine-Saint-Paul, Belgium, 7100
UZ Leuven Recruiting
Leuven, Belgium, 3000
CHU de Liege Recruiting
Liege, Belgium, 4000
CHU UCL Namur asbl - Site Godinne Recruiting
Yvoir, Belgium, 5530
Brazil
Unicamp Universidade Estadual de Campinas Recruiting
Campinas, Brazil, 13083-970
Centro de Pesquisas Oncologicas Recruiting
Florianopolis, Brazil, 88034
Hospital Das Clinicas Da Universidade Federal de Goias Recruiting
Goiania, Brazil, 74680-160
Universidade Federal Do Rio de Janeiro Hospital Universitario Clementino Fraga Filho Recruiting
Rio de Janeiro, Brazil, 21941-913
CEHON - Centro de Hematologia e Oncologia da Bahia Ltda Recruiting
Salvador, Brazil, 40110-090
Clinica Sao Germano Recruiting
Sao Paulo, Brazil, 04537-081
Hospital Israelita Albert Einstein Recruiting
Sao Paulo, Brazil, 05651-901
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 5403000
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
First Affiliated Hospital of Soochow University Recruiting
Suzhou, China, 215006
Colombia
Fundacion Santa Fe de Bogota Recruiting
Bogota, Colombia
Fundacion Oftalmologica de Santander Foscal Recruiting
Floridablanca, Colombia
Hospital Pablo Tobon Uribe Recruiting
Medellin, Colombia
Oncomedica SA Recruiting
Monteria, Colombia
France
Centre Hospitalier Le Mans Recruiting
Le Mans, France, 72000
CHRU de Poitiers La Miletrie Recruiting
Poitiers, France, 86021
Centre Hospitalier Departemental de Vendee Recruiting
Roche-sur-Yon, France, 85000
CHU de Nancy-Hopital Brabois Adulte Recruiting
Vandoeuvre-les-nancy, France, 54211
Germany
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany
Gefos - Gesellschaft fur onkologische Studien mbH Recruiting
Dortmund, Germany
Universitatsklinikum Heidelberg Recruiting
Heidelberg, Germany
Internistisch Hamatologische und Internistische Praxis Recruiting
Herrsching am Ammersee, Germany
Institut fur Versorgungsforschung in der Onkologie GbR Recruiting
Koblenz, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Recruiting
Mainz, Germany
Mannheimer Onkologie Praxis Recruiting
Mannheim, Germany
OnkoNet Marburg GmbH Recruiting
Marburg, Germany
Onkologische Gemeinschaftspraxis Siegburg Completed
Siegburg, Germany
Universitatsklinikum Tubingen Recruiting
Tubingen, Germany
Greece
University Hospital of Alexandroupolis Recruiting
Alexandroupoli, Greece, 68100
Evangelismos General Hospital of Athens Recruiting
Athens, Greece, 10676
Alexandra Hospital Recruiting
Athens, Greece, 11525
University General Hospital of Ioannina Recruiting
Ioannina, Greece, 45500
University General Hospital of Larissa Recruiting
Larisa, Greece, 41110
University General Hospital of Patras Recruiting
Patras, Greece, 26500
Israel
HaEmek Medical Center Recruiting
Afula, Israel, 18371
Lady Davis Carmel Medical Center Recruiting
Haifa, Israel, 34362
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Meir Medical Center Recruiting
Kefar-Sava, Israel, 44281
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Assuta Medical Centers Recruiting
Tel Aviv, Israel, 69710
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi Recruiting
Ancona, Italy, 60020
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi Recruiting
Bologna, Italy, 40138
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Recruiting
Catania, Italy
Azienda Ospedaliera Universitaria Careggi Recruiting
Firenze, Italy, 50134
Azienda Ospedaliera Universitaria Federico II Recruiting
Napoli, Italy
Azienda Policlinico Umberto I Recruiting
Roma, Italy, 00161
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Recruiting
Torino, Italy
Azienda Sanitaria Universitaria Integrata di Udine Recruiting
Udine, Italy, 33100
Mexico
Nucleo Oncologico de Occidente S.C. Recruiting
Guadalajara, Mexico, 44670
Hematologica Alta Especialidad S.C. Recruiting
Huixquilucan, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez Recruiting
Monterrey, Mexico, 64460
Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 8036
Hospital Universitario Virgen de Las Nieves Recruiting
Granada, Spain, 18014
Complejo Asistencial Universitario de Leon Recruiting
Leon, Spain, 24080
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Hospital Universitari i Politecnic La Fe de Valencia Recruiting
Valencia, Spain
Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 807
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan
Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital Recruiting
Puzih City, Taiwan, 613
China Medical University Hospital Recruiting
Taichung City, Taiwan, 40447
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70403
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Turkey
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi Recruiting
Adana, Turkey
Ankara University Medical Faculty Cebeci Hospital Recruiting
Ankara, Turkey
Akdeniz University Medical Faculty Recruiting
Antalya, Turkey
Johns Hopkins Medicine - Anadolu Saglik Merkezi Recruiting
Gebze, Turkey
Ege Universitesi Tip Fakultesi Hastanesi Recruiting
Istanbul, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi Recruiting
Istanbul, Turkey
Dokuz Eylul University Medical Faculty Recruiting
Izmir, Turkey
Erciyes Universitesi Tip Fakultesi Hastanesi Recruiting
Kayseri, Turkey
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi Recruiting
Samsun, Turkey
Karadeniz Technical University Faculty of Medicine Recruiting
Trabzon, Turkey
United Kingdom
Royal United Hospital Recruiting
Bath, United Kingdom
University Hospital Birmingham Recruiting
Birmingham, United Kingdom, B15 2TH
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom, Bh7 7dw
Ninewells Hospital - PPDS Recruiting
Dundee, United Kingdom, DD1 9SY
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, United Kingdom, SM2 5PT
Pinderfields General Hospital Recruiting
Wakefield, United Kingdom, WF1 4DG
Sponsors and Collaborators
Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02761187     History of Changes
Other Study ID Numbers: NSMM-5001
First Submitted: April 28, 2016
First Posted: May 4, 2016
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases