PRospective Multiple Myeloma Impact Study
PROMMIS
Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients
1 other identifier
interventional
250
1 country
9
Brief Summary
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in Multiple Myeloma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-myeloma
Started Feb 2018
Longer than P75 for not_applicable multiple-myeloma
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2016
CompletedFirst Posted
Study publicly available on registry
September 22, 2016
CompletedStudy Start
First participant enrolled
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedApril 28, 2026
April 1, 2026
4.1 years
September 15, 2016
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
3 year Progression Free Survival
3 years after diagnosis
3 year Overall Survival
3 years after diagnosis
5 year Progression Free Survival
5 years after diagnosis
5 year Overall Survival
5 years after diagnosis
Study Arms (1)
MMprofiler SKY92
EXPERIMENTALEligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature
Interventions
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
Eligibility Criteria
You may qualify if:
- Potentially multiple myeloma according to IMWG criteria
- Candidates for systemic treatment
You may not qualify if:
- ECOG Performance Status \> 3
- Tumor sample that fails QA or QC criteria for MMprofiler
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Columbia University Medical Center
New York, New York, 10032, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Wake Forest Baptist Medical Center,
Winston-Salem, North Carolina, 27157, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saad Usmani, MD
Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2016
First Posted
September 22, 2016
Study Start
February 27, 2018
Primary Completion
April 18, 2022
Study Completion (Estimated)
October 1, 2026
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share