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



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:July 1, 2016
End Date:July 1, 2024
Contact:Takeda Study Registration Call Center
Email:GlobalOncologyMedinfo@takeda.com
Phone:1-866-835-2233

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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.

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.

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.
We found this trial at
44
sites
1100 Charlotte Avenue
Nashville, Tennessee 37203
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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1000 South Coulter Street
Amarillo, Texas 79106
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Bolivar, Missouri 65613
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6 Rue Marguerite Depasse
Charleroi, 6060
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Charlotte, North Carolina 28203
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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10710 Charter Drive
Columbia, Maryland 21044
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3410 Worth Street
Dallas, Texas 92056
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224 Memorial Medical Parkway
Daytona Beach, Florida 32117
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1800 North Williams Street
Denver, Colorado 80218
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Detroit, Michigan 48201
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2200 New York 25A
East Hills, New York 11548
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1901 Grandview Avenue
El Paso, Texas 79902
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Farmington, New Mexico 87401
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Flemington, New Jersey 08822
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Fort Collins, Colorado
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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Green Bay, Wisconsin 54301
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Greenville, South Carolina 29605
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Kansas City, Missouri 64128
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Lewiston, Maine 04240
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8901 Carti Way
Little Rock, Arkansas 72205
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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510 Butler Avenue
Martinsburg, West Virginia 25401
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2828 East Barnett Road
Medford, Oregon 97504
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Metairie, Louisiana 70006
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8915 West Golf Road
Niles, Illinois 60714
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Philadelphia, Pennsylvania 19111
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Pittsburgh, Pennsylvania 15232
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265 North Broadway
Portland, Oregon 97227
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2410 Round Rock Avenue
Round Rock, Texas 78681
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Saint Louis, Missouri 63110
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Saint Louis Park, Minnesota 55416
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Saint Petersburg, Florida 33705
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2130 Northeast Interstate 410 Loop
San Antonio, Texas 78217
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Santa Rosa, California 95403
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Washington, District of Columbia 20052
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808 North 39th Avenue
Yakima, Washington 98902
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