Evaluation of Clinical Treatment of Multiple Myeloma Based on Multi-omics

Multiple Myeloma Clinical Trial

Official title:

Evaluating Study of Clinical Treatment of Multiple Myeloma Based on Analytical Omics

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04678089
• Other study ID #: 2020-9-23-7
• Status: Enrolling by invitation
• Start date: May 16, 2019
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With the emergence of new drugs, the short-term survival rate of multiple myeloma has been significantly increased. However, in clinical treatment, doctors found that different patients may present different clinical efficacy and adverse reactions when using standard treatment. Some studies have shown that gene and metabolic differences in patients with multiple myeloma may be an important factor affecting clinical efficacy.

In this project, peripheral blood samples and bone marrow from patients with multiple myeloma will be studied by using the methods of genomics, proteomics, metabonomics and transcriptomics. It is expected to find biomarkers and genes related to clinical efficacy, adverse reactions, and blood concentration of bortezomib in peripheral blood samples. If the sample size is large enough, the project team expects to establish a prediction model for the efficacy and safety of bortezomib containing regimen for multiple myeloma patients through the above studies. Investigators hope that the evaluation system can provide a reference for clinical formulation of appropriate drug delivery scheme.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 350
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• exposure group:

1. Patients diagnosed with multiple myeloma.

2. Patients with fluorescence in situ hybridization report results, and try to obtain genetic diagnosis results.

• healthy control group: Patients diagnosed without multiple myeloma, such as other chronic diseases or blood tumors.

Exclusion Criteria:

1. Patients without complete clinical information.

2. Patients with malignant epidemic diseases.

3. Patients with alcohol abuse or special dietary habit .

4. Patients with digestive system diseases, such as inflammatory bowel disease, intestinal infectious disease or other diseases that may affect digestive system function.

5. Patients with a history of gastrointestinal operation.

6. Patients with severe renal insufficiency without regular dialysis.

7. Patients with other possibilities who has severe liver or kidney function injury without intervention.

Related Conditions & MeSH terms

• Bortezomib
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bortezomib
Objective To observe the safety and efficacy of bortezomib related biomarkers. Including genes, metabolites, etc

Locations

Country	Name	City	State
China	Beijng Chao Yang Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment toxicities:neuritis		From registration to December,2022
Primary	Confirmed responses: Strictly Complete response, sCR		From registration to December,2022
Primary	Confirmed responses: Complete response, CR		From registration to December,2022
Primary	Confirmed responses: Very good partial response, VGPR		From registration to December,2022
Primary	Confirmed responses: Partial response, PR		From registration to December,2022
Primary	Confirmed responses: Minimal remission, MR		From registration to December,2022
Primary	Confirmed responses: Stable disease, SD		From registration to December,2022
Primary	Progressive disease, PD		From registration to December,2022
Secondary	Progression-free survival		From registration to disease progression or date of death from any cause, whichever came first, assessed up to December,2022
Secondary	Overall survival		From registration to death due to any cause, assessed up to December,2022