MMprofiler for Multiple Myeloma

(PROMMIS Trial)

Recruiting at 8 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

250 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment MMprofiler for multiple myeloma?

The research highlights the importance of genetic information and risk stratification in optimizing treatment for multiple myeloma, suggesting that treatments can be tailored based on patient risk categories. This implies that MMprofiler, which may involve genetic profiling, could be effective in identifying high-risk patients and guiding personalized treatment strategies. ^{1 2 3 4 5}

What safety data exists for MMprofiler for Multiple Myeloma?

The available research articles do not provide specific safety data for MMprofiler for Multiple Myeloma or any other conditions. ^{6 7 8 9 10}

How does the MMprofiler treatment for multiple myeloma differ from other treatments?

The MMprofiler treatment is unique because it focuses on risk stratification, which means it tailors the treatment based on the patient's specific risk category, potentially leading to more personalized and effective therapy compared to standard treatments. ^{1 11 12 13 14}

Research Team

Saad Usmani, MD

Principal Investigator

Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Italy pubmed.ncbi.nlm.nih.gov

Multiple myeloma index: verification of a new prognostic approach with evaluation of treatment response. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Predictors of inferior clinical outcome in patients with standard-risk multiple myeloma. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Defining a set of standardised outcome measures for newly diagnosed patients with multiple myeloma using the Delphi consensus method: the IMPORTA project. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Individualized therapy in multiple myeloma: are we there? [2021]

6. England pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Target Adverse Event Profiles for Predictive Safety in the Postmarket Setting. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Tolerability of antiseizure medicines using Lithuanian version of the Liverpool Adverse Events Profile. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A Framework for Safety Evaluation Throughout the Product Development Life-Cycle. [2021]

11. Pakistan pubmed.ncbi.nlm.nih.gov

Correlation between Clinical Factors and Prognosis in Newly Diagnosed Multiple Myeloma. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Myeloma: classification and risk assessment. [2015]

13. Mexico pubmed.ncbi.nlm.nih.gov

Serum calcium is an independent prognostic factor of overall survival in Mexican patients with multiple myeloma. [2017]

14. China pubmed.ncbi.nlm.nih.gov

[Clinical Features and Prognostic Factors of Patients with Multiple Myeloma]. [2021]