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PRospective Multiple Myeloma Impact Study (PROMMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02911571
Recruitment Status : Active, not recruiting
First Posted : September 22, 2016
Last Update Posted : May 13, 2022
Sponsor:
Collaborator:
Medex15
Information provided by (Responsible Party):
SkylineDx

Study Description
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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
Multiple Myeloma Device: MMprofiler SKY92 gene signature Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 27, 2018
Actual Primary Completion Date : April 18, 2022
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in treatment intention [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 years after diagnosis ]
    Duration from start of the treatment to death (regardless of cause of death).

  3. 5 year Progression Free Survival [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911571


Locations
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United States, District of Columbia
Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 20007
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Columbia University Medical Center
New York, New York, United States, 10032
Weill Cornell Medicine
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Wake Forest Baptist Medical Center,
Winston-Salem, North Carolina, United States, 27157
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
SkylineDx
Medex15
Investigators
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Principal Investigator: Saad Usmani, MD Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System
More Information
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Responsible Party: SkylineDx
ClinicalTrials.gov Identifier: NCT02911571    
Other Study ID Numbers: PROMMIS
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases