MMprofiler for Multiple Myeloma

(PROMMIS Trial)

Not currently recruiting at 9 trial locations

Overseen By Femke de Snoo, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SkylineDx

Disqualifiers: ECOG > 3, Tumor sample failure

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a tool called MMprofiler can assist doctors in selecting treatments for multiple myeloma, a type of blood cancer. Researchers will use a specific test on bone marrow samples to collect information that may guide treatment choices. The trial is best suited for individuals who may have multiple myeloma and plan to begin treatment soon. As an unphased trial, it offers patients the chance to contribute to important research that could enhance future treatment decisions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the MMprofiler is safe for use in Multiple Myeloma patients?

Research has shown that MMprofiler SKY92 helps doctors select optimal treatment plans for individuals with multiple myeloma, a type of blood cancer. As it is not a medicine or therapy, it does not carry the same safety concerns as treatments administered into the body.

The test analyzes a sample from a bone marrow biopsy to examine the genes in cancer cells. This analysis helps determine whether a person is at high or standard risk for disease progression. Since MMprofiler SKY92 only processes data from a biopsy, it poses no direct safety risks beyond the usual risks associated with a bone marrow biopsy.

Overall, MMprofiler SKY92 is well-tolerated because it serves as a diagnostic tool, not a treatment with side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MMprofiler for multiple myeloma because it offers a new way to predict the disease's progression using the SKY92 gene signature. Unlike current treatments that focus on direct cancer attack or slowing its growth, MMprofiler analyzes bone marrow samples to provide a personalized prognosis. This innovative approach could help doctors tailor treatments more effectively, potentially leading to better outcomes and more precise care for patients.

What evidence suggests that the MMprofiler is effective for Multiple Myeloma?

Research has shown that the MMprofiler SKY92, studied in this trial, is a valuable tool for understanding multiple myeloma, a type of blood cancer. Studies have found that this test can predict key outcomes such as progression-free survival, which measures how long a patient lives without the cancer worsening, and overall survival, which measures total lifespan. The SKY92 gene signature identifies patients at high risk of cancer recurrence and shorter lifespan, making it a helpful tool for doctors to make informed treatment decisions. The MMprofiler provides a clearer picture of a patient's outlook, aiding doctors in tailoring treatments more effectively. ^{1 3 6 7 8}

Who Is on the Research Team?

Saad Usmani, MD

Principal Investigator

Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I may have multiple myeloma based on specific criteria.

I am a candidate for treatment that affects my whole body.

Exclusion Criteria

The tumor sample does not meet the quality standards for MMprofiler testing.

I am mostly bedridden due to my health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants' tumor samples are analyzed for the MMprofiler SKY92 gene signature to assess treatment intention

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• MMprofiler

Trial Overview 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.

How Is the Trial Designed?

Group I: MMprofiler SKY92 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

SkylineDx

Lead Sponsor

Trials

2

Recruited

2,100+

Medex15

Collaborator

Trials

2

Recruited

320+

Medex15

Industry Sponsor

Trials

3

Recruited

410+

Published Research Related to This Trial

MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.

The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. Yu, Z., Wu, Z., Li, W., et al.[2021]

Multiple myeloma (MM) shows significant clinical and biological diversity, leading to the identification of various prognostic factors and systems, including the International Staging System, which helps categorize patients based on their risk levels.

Recent advancements in genetic profiling have enhanced the ability to identify high-risk patients with shorter survival times, allowing for more tailored treatment strategies based on individual risk categories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk stratification of patients with newly diagnosed multiple myeloma: optimizing treatment based on pretreatment characteristics. Chng, WJ., Fonseca, R.[2020]

The Lithuanian version of the Liverpool Adverse Events Profile (LT-LAEP) is a reliable tool for assessing adverse effects of antiseizure medications in people with epilepsy, showing high internal consistency and test-retest reliability.

Key factors influencing higher LT-LAEP scores include being female, experiencing more frequent seizures, and having higher levels of anxiety and depression, rather than the total amount of medication taken.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of antiseizure medicines using Lithuanian version of the Liverpool Adverse Events Profile. Jasionis, A., Jasionytė, G., Mameniškienė, R.[2021]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

Citations

1. skylinedx.com skylinedx.com/news/new-data-from-prommis-study-highlights-the-power-of-sky92-in-identifying-high-risk-multiple-myeloma-patients/

New Data from PROMMIS Study Highlights the Power of ... MMprofiler with the SKY92 biomarker enhances the biological insights into the diseases. This molecular diagnostic test measures the activity of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S152515782030533X

Analytical Validation of SKY92 for the Identification of High- ... Patients with MM classified as high risk by the SKY92 gene expression classifier are at high risk of relapse and short survival. Analytical validation of the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9290833/

Prognostic gene expression analysis in a retrospective ... Gene expression profiling‐based markers SKY92 and the PR‐cluster were shown to be independent prognostic factors for survival, with hazard ratios and 95% ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02911571

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. Detailed ...

5. nice.org.uk nice.org.uk/advice/mib270/chapter/Clinical-and-technical-evidence

MMprofiler for prognostic risk classification in multiple ... This study validates the use of the MMprofiler SKY92 gene classifier to predict progression-free survival and overall survival in multiple ...

6. skylinedx.com skylinedx.com/sky92/

SKY92 - SkylineDx SKY92 is a molecular diagnostic test developed by SkylineDx designed specifically for patients with Multiple Myeloma (MM) — both newly diagnosed and those with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9175784/

Gene expression profiling impacts treatment decision ... The SKY92 molecular signature classifies patients as standard‐ or high‐risk for progression. The PRospective Observational Multiple Myeloma Impact Study ( ...

8. ashpublications.org ashpublications.org/blood/article/140/Supplement%201/4273/490602/Advanced-Risk-Stratification-in-Multiple-Myeloma

The First Prospective Real-World Evidence for SKY92 Gene ... Advanced risk stratification in multiple myeloma beyond traditional FISH: The first prospective real-world evidence for SKY92 gene expression profiling.