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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Objective To observe the safety and efficacy of bortezomib related biomarkers. Including genes, metabolites, etc |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
exposure group:
healthy control group: Patients diagnosed without multiple myeloma, such as other chronic diseases or blood tumors.
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Lihong Liu, Doctor | Beijing Chao Yang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijng Chao Yang Hospital | Beijing | 100020 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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Peripheral blood samples and bone marrow
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |