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

ArmDescriptionAssigned Intervention
Experimental
MMprofiler SKY92 		Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature
  • Device: 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

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.