Multiple Myeloma
Conditions
Brief summary
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in Multiple Myeloma patients.
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.
Interventions
DEVICEMMprofiler 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
Sponsors
SkylineDx
Medex15
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in treatment intention | Treatment intention is measured before MMprofiler SKY92 and within 4 weeks after MMprofiler | Change in treatment intention will be assessed with a physician questionnaire pre- and post MMprofiler assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3 year Progression Free Survival | 3 years after diagnosis | Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first. |
| 3 year Overall Survival | 3 years after diagnosis | Duration from start of the treatment to death (regardless of cause of death). |
| 5 year Progression Free Survival | 5 years after diagnosis | Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first. |
| 5 year Overall Survival | 5 years after diagnosis | Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSaad Usmani, MD
Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System
Outcome results
None listed