PRospective Multiple Myeloma Impact Study
- Conditions
- Multiple Myeloma
- Interventions
- Device: MMprofiler SKY92 gene signature
- Registration Number
- NCT02911571
- Lead Sponsor
- SkylineDx
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Potentially multiple myeloma according to IMWG criteria
- Candidates for systemic treatment
- ECOG Performance Status > 3
- Tumor sample that fails QA or QC criteria for MMprofiler
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MMprofiler SKY92 MMprofiler SKY92 gene signature Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
3 year Overall Survival 3 years after diagnosis Duration from start of the treatment to death (regardless of cause of death).
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.
Trial Locations
- Locations (9)
Weill Cornell Medicine
🇺🇸New York, New York, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
New York Presbyterian Brooklyn Methodist Hospital
🇺🇸Brooklyn, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Wake Forest Baptist Medical Center,
🇺🇸Winston-Salem, North Carolina, United States