Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
250 participants
INTERVENTIONAL
2018-02-27
2026-09-01
Brief Summary
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Detailed Description
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Eligible patients will have their tumor sample analyzed for the prognostic MMprofiler SKY92, several cytogenetic markers, gene expression markers, and gene expression clusters.
A total of 250 patients will be enrolled from up to 9 US centers. Patients will be followed 5 years after diagnosis.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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MMprofiler SKY92
Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature
MMprofiler SKY92 gene signature
MMprofiler is a gene expression assay system for detection of the presence (or absence) of the SKY92 "high-risk" gene signature to aid in the determination of the Multiple Myeloma patient's prognosis
Interventions
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MMprofiler SKY92 gene signature
MMprofiler is a gene expression assay system for detection of the presence (or absence) of the SKY92 "high-risk" gene signature to aid in the determination of the Multiple Myeloma patient's prognosis
Eligibility Criteria
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Inclusion Criteria
* Candidates for systemic treatment
Exclusion Criteria
* Tumor sample that fails QA or QC criteria for MMprofiler
18 Years
ALL
No
Sponsors
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Medex15
INDUSTRY
SkylineDx
INDUSTRY
Responsible Party
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Principal Investigators
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Saad Usmani, MD
Role: PRINCIPAL_INVESTIGATOR
Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System
Locations
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Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Wake Forest Baptist Medical Center,
Winston-Salem, North Carolina, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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PROMMIS
Identifier Type: -
Identifier Source: org_study_id