Efficacy of Monosialotetrahexosylganglioside in the Prophylactic Treatment of Bortezomib-induced Peripheral Neuropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02093910|
Recruitment Status : Unknown
Verified November 2014 by Xia Zhongjun, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : March 21, 2014
Last Update Posted : November 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Monosialotetrahexosylganglioside||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase 2 Study of Concurrent Monosialotetrahexosylganglioside in the Prophylactic Treatment of Bortezomib-induced Peripheral Neuropathy in Patients of Multiple Myeloma|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||April 2018|
U.S. FDA Resources
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.
- overall incidence rate of peripheral neuropathy (PN) [ Time Frame: up to 6 months ]the grade of peripheral neuropathy (PN) was recorded according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
- duration of peripheral neuropathy (PN) [ Time Frame: up to 1 year (about 6 months after the completion of treatment) ]the duration of peripheral neuropathy means the time from the onset time of peripheral neuropathy (PN) to the relief time of PN
- complete rate (CR) rate [ Time Frame: up to 6 months ]The criteria for CR was according to International Myeloma Working Group Uniform Response Criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093910
|Contact: Zhong-jun Xia, M.D.||email@example.com|
|Contact: Liang Wang, M.D.||firstname.lastname@example.org|
|Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Liang Wang, M.D. 0086-02087342438 email@example.com|
|Principal Investigator: Zhong-jun Xia, M.D.|
|Principal Investigator:||Zhong-jun Xia, M.D.||Sun Yat-sen University|