Bortezomib, Multiple Myeloma
Conditions
Keywords
Genomics, Metabonomics, therapeutic drug monitoring
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.
Interventions
DRUGBortezomib
Objective To observe the safety and efficacy of bortezomib related biomarkers. Including genes, metabolites, etc
Sponsors
Beijing Chao Yang Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive disease, PD | 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | From registration to death due to any cause, assessed up to December,2022 |
| Progression-free survival | From registration to disease progression or date of death from any cause, whichever came first, assessed up to December,2022 |
Countries
China
Outcome results
None listed