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PROMMIS: PRospective Multiple Myeloma Impact Study

Sponsor
SkylineDx (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02911571
Collaborator
Medex15 (Other)
250
Enrollment
9
Locations
1
Arm
90.1
Anticipated Duration (Months)
27.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: MMprofiler SKY92 gene signature
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients
Actual Study Start Date :
Feb 27, 2018
Actual Primary Completion Date :
Apr 18, 2022
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 3 year Overall Survival [3 years after diagnosis]

    Duration from start of the treatment to death (regardless of cause of death).

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lombardi Comprehensive Cancer Center Washington District of Columbia United States 20007
2 Winship Cancer Institute, Emory University Atlanta Georgia United States 30322
3 Hackensack University Medical Center Hackensack New Jersey United States 07601
4 New York Presbyterian Brooklyn Methodist Hospital Brooklyn New York United States 11215
5 Columbia University Medical Center New York New York United States 10032
6 Weill Cornell Medicine New York New York United States 10065
7 Levine Cancer Institute Charlotte North Carolina United States 28204
8 Wake Forest Baptist Medical Center, Winston-Salem North Carolina United States 27157
9 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • SkylineDx
  • Medex15

Investigators

  • Principal Investigator: Saad Usmani, MD, Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SkylineDx
ClinicalTrials.gov Identifier:
NCT02911571
Other Study ID Numbers:
  • PROMMIS
First Posted:
Sep 22, 2016
Last Update Posted:
May 13, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of May 13, 2022