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

NCT ID: NCT02093910

Last Updated: 2014-11-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-04-30

Brief Summary

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Monosialotetrahexosylganglioside

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.

Group Type: EXPERIMENTAL

Monosialotetrahexosylganglioside

Intervention Type: DRUG

Interventions

Monosialotetrahexosylganglioside

Intervention Type: DRUG

Other Intervention Names

bortezomib; dexamethasone

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xia Zhongjun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhong-jun Xia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhong-jun Xia, M.D.

Role: CONTACT

xiazhj@sysucc.org.cn

0086-020-87342438

Liang Wang, M.D.

Role: CONTACT

wangliang@sysucc.org.cn

0086-020-87342439

Facility Contacts

Liang Wang, M.D.

Role: primary

wangliang@sysucc.org.cn

0086-02087342438

Other Identifiers

GM1

Identifier Type: -

Identifier Source: org_study_id