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

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04678089

Collaborator

(none)

350

Enrollment

Location

54.5

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Bortezomib	Drug: Bortezomib

Study Design

Study Type:

Observational

Anticipated Enrollment :

350 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 16, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Health group The healthy control group mainly collected patients with other chronic diseases or blood tumors who did not meet the exclusion criteria and were not diagnosed with multiple myeloma. Also，we need some healthy volunteers. Healthy volunteers refer to people without serious physical disease, immune disease and family history of mental illness.There is no distinction between age, gender and nationality.
Multiple Myeloma group 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.	Drug: Bortezomib Objective To observe the safety and efficacy of bortezomib related biomarkers. Including genes, metabolites, etc Other Names: PS-341 VELCADE

Arm

Intervention/Treatment

Health group

The healthy control group mainly collected patients with other chronic diseases or blood tumors who did not meet the exclusion criteria and were not diagnosed with multiple myeloma. Also，we need some healthy volunteers. Healthy volunteers refer to people without serious physical disease, immune disease and family history of mental illness.There is no distinction between age, gender and nationality.

Multiple Myeloma group

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.

Drug: Bortezomib

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

Other Names:

PS-341

VELCADE

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

exposure group:

Patients diagnosed with multiple myeloma.
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:

Patients without complete clinical information.
Patients with malignant epidemic diseases.
Patients with alcohol abuse or special dietary habit .
Patients with digestive system diseases, such as inflammatory bowel disease, intestinal infectious disease or other diseases that may affect digestive system function.
Patients with a history of gastrointestinal operation.
Patients with severe renal insufficiency without regular dialysis.
Patients with other possibilities who has severe liver or kidney function injury without intervention.