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 |
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.
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.
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
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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
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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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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1515 Holcombe Blvd
Houston, Texas 77030
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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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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600 Highland Ave.
Madison, Wisconsin 53792
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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808 North 39th Avenue
Yakima, Washington 98902
Yakima, Washington 98902
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