Screening Program for Multiple Myeloma

Overseen By Jason Valent, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Non-Black, Under 50 years

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

201 Participants Needed

Trial Summary

What is the purpose of this trial?

This project will pilot the expansion of the existing Taussig Outreach Program's community outreach and patient navigation model to study the multiple myeloma (MM) screening program. This involves analyzing community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This study also aims to gauge the current and general understanding of MM. This study seeks to recruit participants in the pilot screening program to promote early detection. Participants who have abnormal results will receive patient navigation for further diagnostics and testing.

Will I have to stop taking my current medications?

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

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

The use of serum and urine protein electrophoresis (SPEP and UPEP) is important in managing multiple myeloma, as it helps in diagnosing, monitoring treatment response, and detecting relapse. Additionally, the involved free light chain (iFLC) method can detect treatment response or disease progression earlier than traditional methods, providing a more timely assessment of the patient's condition. ^{1 2 3 4 5}

Is the screening program for multiple myeloma safe for humans?

The safety of the screening methods like serum and urine protein electrophoresis (SPEP and UPEP) and immunofixation electrophoresis (IFE) is generally well-established, as these are standard diagnostic tests used in medical practice. They are non-invasive and involve analyzing blood and urine samples, which are considered safe procedures for humans. ^{1 3 4 6 7}

How is the Multiple Myeloma M-Protein Analysis treatment different from other treatments for multiple myeloma?

The Multiple Myeloma M-Protein Analysis treatment is unique because it focuses on early detection and monitoring of the disease through serum and urine protein electrophoresis, which helps in diagnosing multiple myeloma earlier and tracking its progression more effectively compared to traditional symptom-driven approaches. ^{1 3 4 7 8}

Research Team

Jason N. Valent

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for Black and/or African-American individuals who are 50 years or older. It aims to promote early detection of multiple myeloma by screening participants and providing guidance if abnormal results are found.

Inclusion Criteria

Participant self-identifying as, or perceived as, Black and/or African-American

I am 50 years old or older.

Exclusion Criteria

Participants who do not self-identify as Black and/or African American

I am under 50 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Screening Program

Participants partake in a multiple myeloma screening program involving a blood sample and a questionnaire to gauge knowledge of multiple myeloma

12 months

Multiple visits (in-person)

Follow-up

Participants are monitored for changes in knowledge and attitudes towards multiple myeloma after the screening

1 week or more

1 visit (virtual or in-person)

Treatment Details

Interventions

• Multiple Myeloma Knowledge Questionnaires
• Multiple Myeloma M-Protein Analysis

Trial Overview The study tests a community outreach program that includes MM screening using M-Protein analysis, followed by patient navigation for those with abnormal results. It also assesses participant knowledge about MM through questionnaires.

Participant Groups

Group I: Multiple Myeloma Screening Experience Experimental Treatment 2 Interventions

Participants will partake in a multiple myeloma screening program. The screening involves a blood sample and the completion of a questionnaire to gauge participants' multiple myeloma knowledge.

Multiple Myeloma M-Protein Analysis is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as Multiple Myeloma M-Protein Analysis for:

• Diagnosis and monitoring of multiple myeloma

Approved in European Union as Multiple Myeloma M-Protein Analysis for:

• Diagnosis and monitoring of multiple myeloma

Approved in Canada as Multiple Myeloma M-Protein Analysis for:

• Diagnosis and monitoring of multiple myeloma

Approved in Japan as Multiple Myeloma M-Protein Analysis for:

• Diagnosis and monitoring of multiple myeloma

Approved in China as Multiple Myeloma M-Protein Analysis for:

• Diagnosis and monitoring of multiple myeloma

Approved in Switzerland as Multiple Myeloma M-Protein Analysis for:

• Diagnosis and monitoring of multiple myeloma

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

Serum and urine protein electrophoresis are crucial for managing multiple myeloma, helping in diagnosis, treatment response evaluation, and relapse detection.

The Intergroupe francophone du myélome (IFM) provides guidelines to standardize these biochemical analyses across laboratories, aiming to enhance patient monitoring and care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IFM (Intergroupe francophone du myélome) recommendations for uniform interpretation of serum and urine protein electrophoresis in multiple myeloma diagnosis and follow-up. Dejoie, T., Lakomy, D., Caillon, H., et al.[2017]

The daratumumab-specific immunofixation electrophoresis reflex assay (DIRA) effectively distinguishes between daratumumab and residual myeloma protein in patient samples, ensuring accurate monitoring of treatment response.

DIRA demonstrated high specificity and reproducibility, with a sensitivity limit of 0.2 g/L for daratumumab, making it a reliable tool for assessing the impact of monoclonal antibody therapies in myeloma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring multiple myeloma patients treated with daratumumab: teasing out monoclonal antibody interference. McCudden, C., Axel, AE., Slaets, D., et al.[2017]

In a study of 450 multiple myeloma patients, the serum-free light chain (iFLC) method detected treatment responses significantly earlier than standard serum and urine protein electrophoresis (sPEP/uPEP), with a median time of 1.94 months compared to 5.39 months.

iFLC was particularly effective in identifying disease progression sooner than sPEP, especially in patients whose progression occurred more than 18 months after their best response, indicating its potential for earlier intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involved free light chain: an early independent predictor of response and progression in multiple myeloma. Gran, C., Afram, G., Liwing, J., et al.[2021]

Routine serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP) screening in 165 male patients with significant proteinuria (greater than 3 g/d) detected an M-spike in 11.5% of cases, indicating its potential utility in identifying underlying conditions.

Among those with a positive M-spike, 1.2% were diagnosed with myeloma, suggesting that while the tests can be useful, the overall yield for serious conditions like myeloma is relatively low, with a cost of $1,192 per case discovered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of urine and serum protein electrophoresis in evaluation of nephrotic-range proteinuria. Chew, ST., Fitzwilliam, J., Indridason, OS., et al.[2019]

The study found a significant relationship between serum protein electrophoresis (SPE) results and serum immunoglobulin profiles in patients with multiple myeloma (MM), indicating that SPE can aid in diagnosing the disease.

Among 131 patients analyzed, the presence of M bands was associated with increased levels of immunoglobulins, particularly IgG, suggesting that monitoring these proteins can be crucial for early and advanced detection of MM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significance of Serum Protein Electrophoresis in the Detection of Multiple Myeloma: A Diagnostic Interpretation of Patients with Varied Immunoglobulins. Nayak, BS., Ojar-Taylor, N., St John, S., et al.[2022]

Over a 5-year period, a total of 5,086 serum protein electrophoresis (SPE) tests and 1,299 urine protein electrophoresis (UPE) tests were conducted, revealing a significant prevalence of these tests in a South African academic laboratory setting.

Among patients with negative immunofixation tests, 40% of those who underwent bone marrow biopsies were found to have myeloma, indicating that negative electrophoresis results do not rule out the presence of serious conditions like myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophoresis test prevalence, requesting patterns, yield and related bone marrow biopsy findings at a South African tertiary hospital: A 5-year retrospective audit. Naidoo, N., Erasmus, RT., Grewal, R., et al.[2019]

The Hevylite™ immunoassay shows a strong correlation with traditional methods like serum protein electrophoresis (SPE) and immunofixation electrophoresis (IFE) for measuring immunoglobulin concentrations in multiple myeloma patients, with R(2) values of 0.902 for IgA and 0.915 for IgG.

While Hevylite™ can detect relapses earlier than SPE and IFE in some cases, it is less sensitive for detecting residual disease, indicating that it may not provide significant advantages over existing methods for diagnosis and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heavy/light chain specific immunoglobulin ratios provides no additional information than serum proteins electrophoresis and immunofixation for the diagnosis and the follow-up of intact immunoglobulin multiple myeloma patients. Beaumont-Epinette, MP., Moreau, C., Besnard, S., et al.[2015]

A retrospective study of 690,000 people screened for multiple myeloma (MM) using serum protein electrophoresis (SPEP) identified 335 eligible patients, with 151 diagnosed through a screening-driven approach, leading to earlier disease detection and better outcomes.

Patients diagnosed via the screening-driven approach had a significantly higher 3-year overall survival rate (76.9%) compared to those diagnosed based on symptoms (46.6%), indicating that M-protein screening can improve early diagnosis and treatment outcomes for MM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact on early diagnosis and survival outcome of M-protein screening-driven diagnostic approach to multiple myeloma in China: a cohort study. Li, J., Wang, Y., Liu, P.[2020]

References

1. France pubmed.ncbi.nlm.nih.gov

IFM (Intergroupe francophone du myélome) recommendations for uniform interpretation of serum and urine protein electrophoresis in multiple myeloma diagnosis and follow-up. [2017]

2. Germany pubmed.ncbi.nlm.nih.gov

Monitoring multiple myeloma patients treated with daratumumab: teasing out monoclonal antibody interference. [2017]

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

Involved free light chain: an early independent predictor of response and progression in multiple myeloma. [2021]

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

Role of urine and serum protein electrophoresis in evaluation of nephrotic-range proteinuria. [2019]

5. Iran pubmed.ncbi.nlm.nih.gov

Significance of Serum Protein Electrophoresis in the Detection of Multiple Myeloma: A Diagnostic Interpretation of Patients with Varied Immunoglobulins. [2022]

6. South Africa pubmed.ncbi.nlm.nih.gov

Electrophoresis test prevalence, requesting patterns, yield and related bone marrow biopsy findings at a South African tertiary hospital: A 5-year retrospective audit. [2019]

7. France pubmed.ncbi.nlm.nih.gov

Heavy/light chain specific immunoglobulin ratios provides no additional information than serum proteins electrophoresis and immunofixation for the diagnosis and the follow-up of intact immunoglobulin multiple myeloma patients. [2015]

8. Australia pubmed.ncbi.nlm.nih.gov

The impact on early diagnosis and survival outcome of M-protein screening-driven diagnostic approach to multiple myeloma in China: a cohort study. [2020]