PRospective Multiple Myeloma Impact Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Device: MMprofiler SKY92 gene signature


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potentially multiple myeloma according to IMWG criteria Candidates for systemic treatment Exclusion Criteria: ECOG Performance Status > 3 Tumor sample that fails QA or QC criteria for MMprofiler

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMprofiler SKY92<br>Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature | Device: MMprofiler SKY92 gene signature<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |