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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02093910
• Other study ID #: GM1
• Status: Recruiting
• Phase: Phase 2
• First received: March 13, 2014
• Last updated: November 17, 2014
• Start date: April 2014
• Est. completion date: April 2018

Study information

• Verified date: November 2014
• Source: Sun Yat-sen University
• Contact: Zhong-jun Xia, M.D.
• Phone: 0086-020-87342438
• Email: xiazhj[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Peripheral Nervous System Diseases

Intervention

Drug:
• Monosialotetrahexosylganglioside

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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)	Yes
Secondary	complete rate (CR) rate	The criteria for CR was according to International Myeloma Working Group Uniform Response Criteria	up to 6 months	No