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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

Tracking Information
First Submitted Date  ICMJE September 15, 2016
First Posted Date  ICMJE September 22, 2016
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE February 27, 2018
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2016)
  • 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.
  • 3 year Overall Survival [ Time Frame: 3 years after diagnosis ]
    Duration from start of the treatment to death (regardless of cause of death).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRospective Multiple Myeloma Impact Study
Official Title  ICMJE Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: MMprofiler SKY92
Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature
Intervention: Device: MMprofiler SKY92 gene signature
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2016)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2024
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisette Stork, MSc +32479567390 lstork@medex15.com
Contact: Femke de Snoo, MD, PhD fdesnoo@medex15.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02911571
Other Study ID Numbers  ICMJE PROMMIS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SkylineDx
Study Sponsor  ICMJE SkylineDx
Collaborators  ICMJE Medex15
Investigators  ICMJE
Principal Investigator: Saad Usmani, MD Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System
PRS Account SkylineDx
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP