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

• Conditions: Multiple Myeloma; Bortezomib
• Interventions: Drug: Bortezomib

• Registration Number: NCT04678089
• Lead Sponsor: Beijing Chao Yang Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-16
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-21
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Myeloma group	Bortezomib	In the exposure group, all patients with multiple myeloma met the inclusion and did not meet exclusion criteria, including planning for autologous stem cell transplantation or not. There is no distinction between age, gender and nationality.

Primary Outcome Measures

Name	Time	Method
Treatment toxicities:neuritis	From registration to December,2022
Confirmed responses: Strictly Complete response, sCR	From registration to December,2022
Confirmed responses: Complete response, CR	From registration to December,2022
Confirmed responses: Very good partial response, VGPR	From registration to December,2022
Confirmed responses: Partial response, PR	From registration to December,2022
Confirmed responses: Minimal remission, MR	From registration to December,2022
Confirmed responses: Stable disease, SD	From registration to December,2022
Progressive disease, PD	From registration to December,2022

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	From registration to disease progression or date of death from any cause, whichever came first, assessed up to December,2022
Overall survival	From registration to death due to any cause, assessed up to December,2022

Trial Locations

Locations (1)

Beijng Chao Yang Hospital; 🇨🇳 Beijing, China