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

April 21, 2022 updated by: Lihong Liu, Beijing Chao Yang Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100020
        • Beijng Chao Yang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Investigators

  • Principal Investigator: Lihong Liu, Doctor, Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-9-23-7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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