PRospective Multiple Myeloma Impact Study

Multiple Myeloma Clinical Trial

— PROMMIS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02911571
• Other study ID #: PROMMIS
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 27, 2018
• Est. completion date: September 1, 2026

Study information

• Verified date: November 2023
• Source: SkylineDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: September 1, 2026
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	New York Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Columbia University Medical Center	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Lombardi Comprehensive Cancer Center	Washington	District of Columbia
United States	Wake Forest Baptist Medical Center,	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
SkylineDx	Medex15

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	3 year Overall Survival	Duration from start of the treatment to death (regardless of cause of death).	3 years after diagnosis
Secondary	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
Secondary	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