Clinical trial NCT04678089: Evaluation of Clinical Treatment of Multiple Myeloma Based on Multi-omics
Official title: Evaluating Study of Clinical Treatment of Multiple Myeloma Based on Analytical Omics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Bortezomib
Keywords: Genomics
Metabonomics
therapeutic drug monitoring
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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. There is no distinction between age, gender and nationality.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment toxicities:neuritis
timeFrame: From registration to December,2022
measure: Confirmed responses: Strictly Complete response, sCR
timeFrame: From registration to December,2022
measure: Confirmed responses: Complete response, CR
timeFrame: From registration to December,2022
measure: Confirmed responses: Very good partial response, VGPR
timeFrame: From registration to December,2022
measure: Confirmed responses: Partial response, PR
timeFrame: From registration to December,2022
measure: Confirmed responses: Minimal remission, MR
timeFrame: From registration to December,2022
measure: Confirmed responses: Stable disease, SD
timeFrame: From registration to December,2022
measure: Progressive disease, PD
timeFrame: From registration to December,2022
Secondary outcomes:
measure: Progression-free survival
timeFrame: From registration to disease progression or date of death from any cause, whichever came first, assessed up to December,2022
measure: Overall survival
timeFrame: From registration to death due to any cause, assessed up to December,2022
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijng Chao Yang Hospital
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Lihong Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: