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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02911571
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : June 27, 2019
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
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : December 1, 2024

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


Contacts
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Contact: Lisette Stork, MSc +32479567390 lstork@medex15.com
Contact: Femke de Snoo, MD, PhD fdesnoo@medex15.com

Locations
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United States, District of Columbia
Lombardi Comprehensive Cancer Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: David Vesole, MD         
United States, Georgia
Winship Cancer Institute, Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Ajay Nooka, MD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: David Siegel, MD         
Principal Investigator: David Siegel, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Suzanne Lentzsch, MD         
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Ruben Niesvizky, MD         
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Saad Usmani, MD         
Wake Forest Baptist Medical Center, Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Cesar Rodriguez, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Parameswaran Hari, MD         
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: June 27, 2019
Last Verified: June 2019
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