Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma

Study Overview
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Brief Summary
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It is an observational, case-control study aimed at early-detection of multiple myeloma and constructing a prognostic model of multiple myeloma. The study will enroll approximately 398 participants including patients with multiple myeloma, patients with benign hematologic disorders and healthy participants.

Official Title
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Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Myeloma: a Proof of Concept Study

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Diagnostic Test: cfDNA methylation assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Cancer Participants: Age 40-75 years Ability to provide a written informed consent Pathologically confirmed diagnosis of multiple myeloma or highly suspicious cases of multiple myeloma No prior or ongoing anti-cancer treatment (local or systematic) prior to study blood draw Inclusion Criteria for Benign Disease Participants: Age 40-75 years Ability to provide a written informed consent Pathologically confirmed diagnosis of benign hematologic disorders or highly suspicious cases with benign hematologic disorders No prior or ongoing radical treatment of the benign hematologic disorders prior to study blood draw Inclusion Criteria for Healthy Participants Age 40-75 years Ability to provide a written informed consent No cancer-related symptoms or other uncomfortable symptoms prior to study blood draw Exclusion Criteria for All Participants: Insufficient qualified blood samples Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant Recipient of blood transfusion within 7 days prior to blood draw Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen) Additional Exclusion Criteria for Cancer Participants: • Other current malignant diseases or multiple primary tumors Additional Exclusion Criteria for Benign Disease Participants: • Current or history of malignancies Additional Exclusion Criteria for Healthy Participants: Recipient of anti-infectious therapy within 14 days prior to study blood draw Prior or ongoing treatment of cancer within 3 years prior to study blood draw Current autoimmune disease or clinically significant or uncontrolled comorbidities

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer Arm<br>participants with newly diagnosed multiple myeloma, from whom blood samples will be collected. | Diagnostic Test: cfDNA methylation assessment<br>* An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment<br>|
| Benign Arm<br>Participants with newly diagnosed benign hematologic disorders, from whom blood samples will be collected. | Diagnostic Test: cfDNA methylation assessment<br>* An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment<br>|
| Healthy arm<br>Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected. | Diagnostic Test: cfDNA methylation assessment<br>* An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of a cfDNA methylation-based early detection model for multiple myeloma at different clinical stages. |  | 12 months | 
| The performance of a cfDNA methylation-based prognostic model for multiple myeloma. | Treatment response and survival outcomes, measured by ORR, CR, PFS, and OS, in high-risk group and low-risk group of multiple myeloma. | 12 months | 
| The specific cfDNA methylation landscape of multiple myeloma in China | The differently methylated regions(DMRs) between multiple myeloma and healthy/benign controls. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple myeloma, early detection, liquid biopsy