PRospective Multiple Myeloma Impact Study (PROMMIS)

SkylineDx

Status: Active, not recruiting

Conditions: Multiple Myeloma

Treatments: Device: MMprofiler SKY92 gene signature

Study type: Interventional

Funder types: Industry

Identifiers

NCT02911571

PROMMIS

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

MMprofiler SKY92

Experimental group

Description:

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

Treatment:

Device: MMprofiler SKY92 gene signature