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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment intention is measured before mmprofiler sky92 and within 4 weeks after mmprofiler
Awards & highlights
PROMMIS Trial 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.Check my eligibility
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.See study design
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.
PROMMIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment intention is measured before mmprofiler sky92 and within 4 weeks after mmprofiler
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment intention is measured before mmprofiler sky92 and within 4 weeks after mmprofiler
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in treatment intention
Secondary outcome measures
3 year Overall Survival
3 year Progression Free Survival
5 year Overall Survival
+1 morePROMMIS 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
2,340 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I may have multiple myeloma based on specific criteria.I am a candidate for treatment that affects my whole body.The tumor sample does not meet the quality standards for MMprofiler testing.I am mostly bedridden due to my health condition.
Research Study Groups:
This trial has the following groups:- Group 1: MMprofiler SKY92
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many facilities are administering this clinical experiment?
"This medical study is currently operating in nine different locations, some of which include Atlanta, Winston-Salem and Washington. It would be beneficial to choose a nearby clinic to help reduce travel demands if you decide to take part."
Answered by AI
Are there any openings to enrol in this clinical trial?
"According to clinicaltrials.gov, this study is not currently recruiting volunteers; the trial was initiated in late February 2018 and updated last October. However, there are 807 other trials that seek participation at present."
Answered by AI
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