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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05693012
• Other study ID #: RSCD2022004
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Lugui Qiu, MD, Ph.D
• Phone: 23909172
• Email: qiulg[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 398
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Diagnostic Test:
• cfDNA methylation assessment
An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment

Locations

Country	Name	City	State
China	National Clinical Research Center for Blood Diseases, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Qiu Lugui	Guangzhou Burning Rock Dx Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of a cfDNA methylation-based early detection modelfor multiple myeloma.		12 months
Secondary	The sensitivity and specificity of a cfDNA methylation-based early detection model for multiple myeloma at different clinical stages.		12 months
Secondary	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
Secondary	The specific cfDNA methylation landscape of multiple myeloma in China	The differently methylated regions(DMRs) between multiple myeloma and healthy/benign controls.	12 months