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Bortezomib was an important drug in the treatment of multiple myeloma (MM),and peripheral neuropathy (PN) is a significant dose-limiting toxicity of bortezomib that typically occurs within the first courses of bortezomib, reaches a plateau at cycle 5. Up to now, no effective prophylaxis have been developed for PN. Monosialotetrahexosylganglioside, a nerve-protecting drug,was often used to promote growth of nerve, and function restoration of damaged nerve.Thus,the investigators hypothesized that combination of Monosialotetrahexosylganglioside and bortezomib can reduce the incidence rate of peripheral neuropathy (PN) and promote the relief of peripheral neuropathy (PN) in multiple myeloma (MM) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monosialotetrahexosylganglioside | Experimental | each patient in this arm received velcade+dexamethasone (VD) regimen(bortezomib,1.3mg/㎡,subcutaneously injection,d1,8,15,22;dexamethasone,20mg d1-2, 8-9,15-16,22-23)every 4 weeks; and monosialotetrahexosylganglioside was used at the dosage of 100mg/d intravenously at d1-2,8-9,15-16,22-23 every cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monosialotetrahexosylganglioside | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| overall incidence rate of peripheral neuropathy (PN) | the grade of peripheral neuropathy (PN) was recorded according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| duration of peripheral neuropathy (PN) | the duration of peripheral neuropathy means the time from the onset time of peripheral neuropathy (PN) to the relief time of PN | up to 1 year (about 6 months after the completion of treatment) |
| complete rate (CR) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhong-jun Xia, M.D. | Contact | 0086-020-87342438 | xiazhj@sysucc.org.cn | |
| Liang Wang, M.D. | Contact | 0086-020-87342439 | wangliang@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhong-jun Xia, M.D. | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China, | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D005677 | G(M1) Ganglioside |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D005732 | Gangliosides |
| D020384 | Acidic Glycosphingolipids |
| D006028 | Glycosphingolipids |
| D006017 | Glycolipids |
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The criteria for CR was according to International Myeloma Working Group Uniform Response Criteria |
| up to 6 months |
| 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 |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D006001 |
| Glycoconjugates |
| D002241 | Carbohydrates |
| D008055 | Lipids |
| D013107 | Sphingolipids |
| D008563 | Membrane Lipids |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |