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MMprofiler for Multiple Myeloma (PROMMIS Trial)

N/A
Waitlist Available
Led By Saad Usmani, MD
Research Sponsored by SkylineDx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
ECOG Performance Status > 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment intention is measured before mmprofiler sky92 and within 4 weeks after mmprofiler
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether a new tool called MMprofiler can help make treatment decisions for Multiple Myeloma patients.

Who is the study for?
This trial is for individuals who may have multiple myeloma based on IMWG criteria and are candidates for systemic treatment. Participants must be able to perform daily activities with relative ease (ECOG Performance Status ≤ 3). They cannot join if their tumor samples fail quality assessments for the MMprofiler test.
What is being tested?
The study is examining how the MMprofiler, which analyzes a specific gene signature in multiple myeloma patients, affects doctors' decisions about treatment plans. It's an observational study focusing on whether this genetic test influences treatment strategies.
What are the potential side effects?
Since this trial involves a diagnostic procedure rather than a drug or therapy, there are no direct side effects from interventions like those seen with medications. However, standard risks associated with medical procedures such as discomfort or bruising at the biopsy site may occur.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am mostly bedridden due to my health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment intention is measured before mmprofiler sky92 and within 4 weeks after mmprofiler
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment intention is measured before mmprofiler sky92 and within 4 weeks after mmprofiler for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in treatment intention
Secondary study objectives
3 year Overall Survival
3 year Progression Free Survival
5 year Overall Survival
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MMprofiler SKY92Experimental Treatment1 Intervention
Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature

Find a Location

Who is running the clinical trial?

Medex15UNKNOWN
2 Previous Clinical Trials
165 Total Patients Enrolled
SkylineDxLead Sponsor
1 Previous Clinical Trials
1,820 Total Patients Enrolled
Saad Usmani, MDPrincipal InvestigatorCharlotte Mecklenburg Hospital Authority, Carolinas HealthCare System
6 Previous Clinical Trials
137 Total Patients Enrolled
6 Trials studying Multiple Myeloma
137 Patients Enrolled for Multiple Myeloma

Media Library

MMprofiler SKY92 gene signature Clinical Trial Eligibility Overview. Trial Name: NCT02911571 — N/A
Multiple Myeloma Research Study Groups: MMprofiler SKY92
Multiple Myeloma Clinical Trial 2023: MMprofiler SKY92 gene signature Highlights & Side Effects. Trial Name: NCT02911571 — N/A
MMprofiler SKY92 gene signature 2023 Treatment Timeline for Medical Study. Trial Name: NCT02911571 — N/A
~33 spots leftby Nov 2025