PRospective Multiple Myeloma Impact Study (PROMMIS)

Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients

This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in Multiple Myeloma patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Device: MMprofiler SKY92 gene signature

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Lombardi Comprehensive Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Presbyterian Brooklyn Methodist Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center,
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 year Progression Free Survival	Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.	3 years after diagnosis
3 year Overall Survival	Duration from start of the treatment to death (regardless of cause of death).	3 years after diagnosis
5 year Progression Free Survival	Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.	5 years after diagnosis
5 year Overall Survival	Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.	5 years after diagnosis

Collaborators and Investigators

• Sponsor: SkylineDx
• Collaborators: Medex15
• Investigators: Principal Investigator: Saad Usmani, MD, Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Actual): April 18, 2022
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 15, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (Estimated): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: PROMMIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No