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| Name | Class |
|---|---|
| Medex15 | INDUSTRY |
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This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in Multiple Myeloma patients.
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in MM patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMprofiler SKY92 | Experimental | Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMprofiler SKY92 gene signature | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in treatment intention | Change in treatment intention will be assessed with a physician questionnaire pre- and post MMprofiler assessment | Treatment intention is measured before MMprofiler SKY92 and within 4 weeks after MMprofiler |
| Measure | Description | Time Frame |
|---|---|---|
| 3 year Progression Free Survival | Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first. | 3 years after diagnosis |
| 3 year Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saad Usmani, MD | Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| Winship Cancer Institute, Emory University |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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Duration from start of the treatment to death (regardless of cause of death).
| 3 years after diagnosis |
| 5 year Progression Free Survival | Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first. | 5 years after diagnosis |
| 5 year Overall Survival | Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first. | 5 years after diagnosis |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| New York Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Wake Forest Baptist Medical Center, | Winston-Salem | North Carolina | 27157 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |