PRospective Multiple Myeloma Impact Study
Purpose
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in Multiple Myeloma patients.
Condition
- Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental MMprofiler SKY92 |
Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature |
|
Recruiting Locations
More Details
- NCT ID
- NCT02911571
- Status
- Active, not recruiting
- Sponsor
- SkylineDx
Detailed Description
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.