Efficacy of Monosialotetrahexosylganglioside in the Prophylactic Treatment of Bortezomib-induced Peripheral Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Study of Concurrent Monosialotetrahexosylganglioside in the Prophylactic Treatment of Bortezomib-induced Peripheral Neuropathy in Patients of Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Monosialotetrahexosylganglioside


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic diagnosis of multiple myeloma; Age:18-80 years; Eastern Cooperative Oncology Group (ECOG) status 0-3, Estimated survival time > 3 months; Acceptable liver function (bilirubin<2.5×ULN, Alanine transaminase (ALT) or Aspartate Aminotransferase (AST)<2.5×ULN), No history of other malignancies; No previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation; No other serious diseases which conflict with the treatment in the present trial; No concurrent treatments that conflict with the treatments in the present trial; Voluntary participation and signed the informed consent. Exclusion Criteria: The patients had the conditions below: clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), symptomatic coronary artery heart disease requiring medication; The patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies; The patients with neuropathy; The patients with mentally ill / unable to obtain informed consent; The patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results; The patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects; The patients with a history of allergy to test drug; The patients not suitable to participate in the investigator judged by researchers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monosialotetrahexosylganglioside<br>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. | Drug: Monosialotetrahexosylganglioside<br> <br> * Other names: dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | The criteria for CR was according to International Myeloma Working Group Uniform Response Criteria | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple myeloma, peripheral neuropathy, prophylaxis