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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new screening method for multiple myeloma, a type of blood cancer. It aims to assess community reception and its effectiveness in early detection. Participants will undergo a blood test called Multiple Myeloma M-Protein Analysis and answer questions about their knowledge of the disease. The trial seeks Black and/or African-American individuals aged 50 years or older. If results indicate something unusual, participants will receive guidance for further testing. As an unphased trial, it offers a unique opportunity to contribute to research that could lead to earlier detection and better outcomes for the community.

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 prior data suggests that this screening program is safe?

Research has shown that the Multiple Myeloma M-Protein Analysis, which includes serum protein electrophoresis (SPEP), is generally safe. SPEP is a blood test that detects antibodies and identifies proteins related to multiple myeloma. This non-invasive test involves only a simple blood draw.

No evidence indicates serious side effects from these tests. They are well-tolerated and commonly used in medical settings. Most people experience only minor discomfort from the blood draw, such as a small bruise or slight pain at the needle site. Reports of major problems linked to the M-Protein Analysis tests do not exist.

In summary, the Multiple Myeloma M-Protein Analysis used in this screening program is safe and causes minimal discomfort, making it a low-risk option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multiple Myeloma M-Protein Analysis because it represents a fresh approach to early detection. Unlike standard treatments that focus on addressing symptoms and slowing disease progression, this screening method aims to catch multiple myeloma at its earliest stages. By analyzing M-protein levels in the blood, it could potentially identify the condition before it becomes symptomatic, offering a proactive strategy rather than a reactive one. This early detection could lead to better outcomes by allowing interventions to start sooner, ultimately improving patient prognosis.

What evidence suggests that this screening program is effective for early detection of multiple myeloma?

Research has shown that analyzing M-Protein is crucial for diagnosing multiple myeloma, a type of blood cancer. In this trial, participants will undergo a screening program that includes M-Protein analysis. Immunofixation electrophoresis (IFE) is the standard test to confirm M-Protein in patients. This test can detect multiple myeloma early, even before symptoms appear. Early detection through screening can lead to better management and outcomes for patients. Studies also indicate that using this test alongside others helps adhere more closely to medical guidelines, ensuring more effective monitoring and treatment planning. ^{1 6 7 8 9}

Who Is on the Research Team?

Jason N. Valent

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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

I am 50 years old or older.

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

Exclusion Criteria

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

I am under 50 years old.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11342076/

Impact of M‐protein detection on the response evaluations ... Immunofixation electrophoresis (IFE) is the standard method for confirming the presence of a monoclonal protein (M‐protein) at multiple myeloma (MM) diagnosis.

2. nature.com nature.com/articles/s41598-025-96565-8

Dynamic monitoring of M-protein quantification by ... Dynamic monitoring of M-protein quantification by immunotyping using capillary zone electrophoresis during the chemotherapy of patients with ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123133556

M-Protein Analysis Test: Effects of Combining Serum ... Combining the SPEP and sFLC into one order test from two separate tests improved adherence to IMWG guidelines for getting both tests ordered (from 45% to 100%).

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cam4.6859

Update on the outcome of M‐protein screening program ... This study updated 7-year follow-up findings of MM patients diagnosed by screening-driven and symptom-driven approaches.

5. cancer.org cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/testing.html

Tests for Multiple Myeloma Different types of lab tests can be helpful in finding multiple myeloma, learning more about it, and seeing how well treatment is working.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9797962/

MALDI-TOF-MS for rapid screening analysis of M-protein in ... We developed a MALDI-TOF Mass spectrometry-based method for the screening test of M-proteins in human serum.

7. myeloma.org myeloma.org/what-are-mgus-smm-mm

MGUS, Smoldering & Active Myeloma: Risk Factors & Signs Tests for M-Proteins. The laboratory tests used to measure the amount of M-protein include the following: serum protein electrophoresis (SPEP); urine protein ...

8. labcorp.com labcorp.com/tests/120256/immunofixation-ife-serum-protein-electrophoresis-pe-serum-and-quantitative-free-and-light-chains-flc-plus-ratio-serum

Immunofixation (IFE), Serum, Protein Electrophoresis (PE), ... International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders. Leukemia. 2009 Feb; 23(2): 215 ...

9. mountsinai.org mountsinai.org/health-library/tests/protein-electrophoresis-serum

Protein electrophoresis - serum Information Increased gamma globulin proteins may indicate: Blood cancers, including multiple myeloma, Waldenström macroglobulinemia, lymphomas, and chronic lymphocytic ...