The INSIGHT MM Study: A global, prospective, non-interventional, observational study of presentation, treatment patterns, and outcomes in multiple myeloma

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Overview

Clinical studies are meant to evaluate and improve treatment and care of patients.

In an observational study, investigators (healthcare professionals) watch people diagnosed with a specific disease, such as multiple myeloma, and record various aspects of their health. People involved in observational studies do not get any treatment in addition to what they are already getting as part of their everyday care.

What is INSIGHT MM?

The INSIGHT MM study will be the largest pharmaceutical company-sponsored study of its kind in multiple myeloma, with the goal to enroll up to 4,200 patients 18 years or older with newly diagnosed or relapsed/refractory multiple myeloma globally.

The INSIGHT MM study is led by a steering committee of myeloma experts.

The purpose of this observational study is to collect information regarding your medical history and how your condition is managed during your routine treatment.

The study may provide a better understanding of current multiple myeloma patients globally, and ways in which they are cared for after they are diagnosed.

What does participation in the study look like?

  • If you agree to join the study, the study team will go over the details of participation using a document called an Informed Consent Form (ICF). After you read the form, you can ask whatever questions you have about the study before you sign the consent form. 
  • If you decide to participate, you will be asked to complete a patient survey and validated questionnaires during the course of the study. Data will be gathered via routine visits, medical records, and patient self-reported outcomes. However, no additional procedures or examinations are required to take part in the study. 

The study is split into 2 periods:

  1. Enrollment Period. This period will consist of the informed consent process, obtaining your signature on the Patient Information Sheet and Informed Consent Signature Form, and collection of the historical and initial data. 
  2. Follow-Up Period. You will participate in the study for (1) at least 5 years up to a maximum of 8 years or (2) until you leave the study or (3) the observational study ends, whichever comes first. During this time, you will be asked to complete questionnaires which are distributed every 3 months.
SparkCures ID 819
Trial Phase Observational Trial
Enrollment 4200 Patients
Trial Sponsors
  • Takeda Oncology
NCT Identifier

NCT02761187

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

You may be eligible to participate in this study if you…

  • Are 18 years of age or older.
  • Are newly diagnosed with multiple myeloma and within 3 months from initiation of treatment 
  • Have relapsed/refractory multiple myeloma and have received 1 to 3 prior lines of therapy
  • Are willing and able to complete patient assessment questionnaires.

Please note: You may not be eligible for this study if:

  • You are reporting to one of the sites listed below for a second opinion (consultation only) or,
  • Your frequency of consult and follow-up are not adequate for quarterly electronic case report form (eCRF) completion.

The following criteria is provided for health care professionals.

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.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Texas Oncology (Round Rock Cancer Center)
Texas Oncology (Round Rock Cancer Center)

Round Rock, TX

Hematology Oncology Associates<br />Providence Cancer Center
Hematology Oncology Associates
Providence Cancer Center

Medford, OR

Compass Oncology
Compass Oncology

Portland, OR

Fox Chase Cancer Center<br />Temple Health
Greenville Health System<br />Blood and Marrow Transplant Program
Greenville Health System
Blood and Marrow Transplant Program

Greenville, SC

Tennessee Oncology<br />Centennial Clinic
Tennessee Oncology
Centennial Clinic

Nashville, TN

Texas Oncology<br />San Antonio Northeast
Texas Oncology
San Antonio Northeast

San Antonio, TX

San Juan Oncology Associates
San Juan Oncology Associates

Farmington, NM

Texas Oncology<br />Amarillo Cancer Center
Texas Oncology
Amarillo Cancer Center

Amarillo, TX

Texas Oncology<br />El Paso Cancer Treatment Center
Texas Oncology
El Paso Cancer Treatment Center

El Paso, TX

Texas Oncology<br />Presbyterian Cancer Center Dallas
Texas Oncology
Presbyterian Cancer Center Dallas

Dallas, TX

Yakima Valley Memorial Hospital<br />North Star Lodge Cancer Center
Yakima Valley Memorial Hospital
North Star Lodge Cancer Center

Yakima, WA

Green Bay Oncology<br />Saint Vincent Hospital
Green Bay Oncology
Saint Vincent Hospital

Green Bay, WI

Mount Sinai Hospital<br />Tisch Cancer Institute
Hunterdon Medical Center
Hunterdon Medical Center

Flemington, NJ

Moores Cancer Center<br />UC San Diego Health
Florida Cancer Specialists<br />North
Florida Cancer Specialists
North

St. Petersburg, FL

St. Joseph Heritage Healthcare
St. Joseph Heritage Healthcare

Santa Rosa, CA

St. Francis Medical Center<br />Catholic Health Initiatives
St. Francis Medical Center
Catholic Health Initiatives

Colorado Springs, CO

UCHealth Poudre Valley Hospital<br />University of Colorado Health
UCHealth Poudre Valley Hospital
University of Colorado Health

Fort Collins, CO

Florida Cancer Specialists<br />Daytona Cancer Center
Florida Cancer Specialists
Daytona Cancer Center

Daytona Beach, FL

Florida Cancer Specialists<br />South
Florida Cancer Specialists
South

Fort Myers, FL

Illinois Cancer Specialists
Illinois Cancer Specialists

Niles, IL

Levine Cancer Institute<br />Atrium Health
Indiana University Health
Indiana University Health

Indianapolis, IN

East Jefferson General Hospital
East Jefferson General Hospital

Metairie, LA

Maryland Oncology Hematology<br />Columbia
Maryland Oncology Hematology
Columbia

Columbia, MD

Park Nicollet Clinic (Saint Louis Park)
Park Nicollet Clinic (Saint Louis Park)

St. Louis Park, MN

Central Care Cancer Center
Central Care Cancer Center

Bolivar, MO

Kansas City VA Medical Center
Kansas City VA Medical Center

Kansas City, MO

Arkansas
University of Arkansas for Medical Sciences (UAMS)
California
Moores Cancer Center<br />UC San Diego Health
St. Joseph Heritage Healthcare
St. Joseph Heritage Healthcare

Santa Rosa, CA

Colorado
St. Francis Medical Center<br />Catholic Health Initiatives
St. Francis Medical Center
Catholic Health Initiatives

Colorado Springs, CO

Rocky Mountain Cancer Centers<br />Denver - Midtown
UCHealth Poudre Valley Hospital<br />University of Colorado Health
UCHealth Poudre Valley Hospital
University of Colorado Health

Fort Collins, CO

Florida
Florida Cancer Specialists<br />Daytona Cancer Center
Florida Cancer Specialists
Daytona Cancer Center

Daytona Beach, FL

Florida Cancer Specialists<br />South
Florida Cancer Specialists
South

Fort Myers, FL

Florida Cancer Specialists<br />North
Florida Cancer Specialists
North

St. Petersburg, FL

Illinois
Illinois Cancer Specialists
Illinois Cancer Specialists

Niles, IL

Indiana
Indiana University Health
Indiana University Health

Indianapolis, IN

Louisiana
East Jefferson General Hospital
East Jefferson General Hospital

Metairie, LA

Maryland
Maryland Oncology Hematology<br />Columbia
Maryland Oncology Hematology
Columbia

Columbia, MD

Minnesota
Park Nicollet Clinic (Saint Louis Park)
Park Nicollet Clinic (Saint Louis Park)

St. Louis Park, MN

Missouri
Central Care Cancer Center
Central Care Cancer Center

Bolivar, MO

Kansas City VA Medical Center
Kansas City VA Medical Center

Kansas City, MO

Siteman Cancer Center<br />Washington University Medical Campus
New Jersey
Hunterdon Medical Center
Hunterdon Medical Center

Flemington, NJ

New Mexico
San Juan Oncology Associates
San Juan Oncology Associates

Farmington, NM

New York
Mount Sinai Hospital<br />Tisch Cancer Institute
North Carolina
Levine Cancer Institute<br />Atrium Health
Ohio
Barrett Cancer Center<br />University of Cincinnati Health
Oregon
Hematology Oncology Associates<br />Providence Cancer Center
Hematology Oncology Associates
Providence Cancer Center

Medford, OR

Compass Oncology
Compass Oncology

Portland, OR

Pennsylvania
Fox Chase Cancer Center<br />Temple Health
South Carolina
Greenville Health System<br />Blood and Marrow Transplant Program
Greenville Health System
Blood and Marrow Transplant Program

Greenville, SC

Tennessee
Tennessee Oncology<br />Centennial Clinic
Tennessee Oncology
Centennial Clinic

Nashville, TN

Texas
Texas Oncology<br />Amarillo Cancer Center
Texas Oncology
Amarillo Cancer Center

Amarillo, TX

Texas Oncology<br />Presbyterian Cancer Center Dallas
Texas Oncology
Presbyterian Cancer Center Dallas

Dallas, TX

Texas Oncology<br />El Paso Cancer Treatment Center
Texas Oncology
El Paso Cancer Treatment Center

El Paso, TX

MD Anderson Cancer Center<br />The University of Texas
Texas Oncology (Round Rock Cancer Center)
Texas Oncology (Round Rock Cancer Center)

Round Rock, TX

Texas Oncology<br />San Antonio Northeast
Texas Oncology
San Antonio Northeast

San Antonio, TX

Washington
Yakima Valley Memorial Hospital<br />North Star Lodge Cancer Center
Yakima Valley Memorial Hospital
North Star Lodge Cancer Center

Yakima, WA

Wisconsin
Green Bay Oncology<br />Saint Vincent Hospital
Green Bay Oncology
Saint Vincent Hospital

Green Bay, WI

UW Carbone Cancer Center<br />University of Wisconsin Health
International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please note the information provided through the government website may be inaccurate and/or out-dated.

Resources

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