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NCT Number: NCT02911571

PRospective Multiple Myeloma Impact Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lombardi Comprehensive Cancer Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MMprofiler SKY92 gene signature

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

SkylineDx

Industry

Collaborators

  • Medex15

Registry information

Official study title

Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients

Acronym: PROMMIS

Important dates

Study start
2018
Primary completion
2022
Study completion
2026
First posted
Sep 22, 2016
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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