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PRospective Multiple Myeloma Impact Study (PROMMIS)

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MMprofiler SKY92 gene signature
Sponsored by
SkylineDx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lombardi Comprehensive Cancer Center
  • Winship Cancer Institute, Emory University
  • Hackensack University Medical Center
  • New York Presbyterian Brooklyn Methodist Hospital
  • Columbia University Medical Center
  • Weill Cornell Medicine
  • Levine Cancer Institute
  • Wake Forest Baptist Medical Center,
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MMprofiler SKY92

Arm Description

Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature

Outcomes

Primary Outcome Measures

Change in treatment intention
Change in treatment intention will be assessed with a physician questionnaire pre- and post MMprofiler assessment

Secondary Outcome Measures

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 year Overall Survival
Duration from start of the treatment to death (regardless of cause of death).
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 year Overall Survival
Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.

Full Information

First Posted
September 15, 2016
Last Updated
October 28, 2022
Sponsor
SkylineDx
Collaborators
Medex15
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1. Study Identification

Unique Protocol Identification Number
NCT02911571
Brief Title
PRospective Multiple Myeloma Impact Study
Acronym
PROMMIS
Official Title
Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
April 18, 2022 (Actual)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SkylineDx
Collaborators
Medex15

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MMprofiler SKY92
Arm Type
Experimental
Arm Description
Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature
Intervention Type
Device
Intervention Name(s)
MMprofiler SKY92 gene signature
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in treatment intention
Description
Change in treatment intention will be assessed with a physician questionnaire pre- and post MMprofiler assessment
Time Frame
Treatment intention is measured before MMprofiler SKY92 and within 4 weeks after MMprofiler
Secondary Outcome Measure Information:
Title
3 year Progression Free Survival
Description
Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
Time Frame
3 years after diagnosis
Title
3 year Overall Survival
Description
Duration from start of the treatment to death (regardless of cause of death).
Time Frame
3 years after diagnosis
Title
5 year Progression Free Survival
Description
Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
Time Frame
5 years after diagnosis
Title
5 year Overall Survival
Description
Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
Time Frame
5 years after diagnosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad Usmani, MD
Organizational Affiliation
Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New York Presbyterian Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Wake Forest Baptist Medical Center,
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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PRospective Multiple Myeloma Impact Study

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