Efficacy of Monosialotetrahexosylganglioside in the Prophylactic Treatment of Bortezomib-induced Peripheral Neuropathy
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- overall incidence rate of peripheral neuropathy (PN) [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]The criteria for CR was according to International Myeloma Working Group Uniform Response Criteria
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02093910
|Contact: Zhong-jun Xia, M.D.||firstname.lastname@example.org|
|Contact: Liang Wang, M.D.||email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Zhong-jun Xia, M.D.|
|Principal Investigator:||Zhong-jun Xia, M.D.||Sun Yat-sen University|