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

NCT04678089 | Unknown

• 1 other identifier: 2020-9-23-7
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Bortezomib

Keywords

Genomics; Metabonomics; therapeutic drug monitoring

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

Interventions

Bortezomib DRUG

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

Also known as: PS-341, VELCADE

Multiple Myeloma group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijng Chao Yang Hospital

Beijing, 100020, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples and bone marrow

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lihong Liu, Doctor

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 21, 2020
• Study Start: May 16, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

CN (1)