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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,
Guangzhou, Guangdong, China
RECRUITINGoverall 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.
Time frame: up to 6 months
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
Time frame: up to 1 year (about 6 months after the completion of treatment)
complete rate (CR) rate
The criteria for CR was according to International Myeloma Working Group Uniform Response Criteria
Time frame: up to 6 months
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