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

NCT02093910 | Unknown Phase 2

• 1 other identifier: GM1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

multiple myeloma; peripheral neuropathy; prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• duration of peripheral neuropathy (PN)

  up to 1 year (about 6 months after the completion of treatment)

• complete rate (CR) rate

  up to 6 months

Study Arms (1)

Monosialotetrahexosylganglioside

EXPERIMENTAL

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

Interventions

Monosialotetrahexosylganglioside DRUG

Also known as: bortezomib, dexamethasone

Monosialotetrahexosylganglioside

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Peripheral Nervous System Diseases

Interventions

G(M1) Ganglioside; Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Gangliosides; Acidic Glycosphingolipids; Glycosphingolipids; Glycolipids; Glycoconjugates; Carbohydrates; Lipids; Sphingolipids; Membrane Lipids; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Zhong-jun Xia, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhong-jun Xia, M.D.

CONTACT

0086-020-87342438; xiazhj@sysucc.org.cn

Liang Wang, M.D.

CONTACT

0086-020-87342439; wangliang@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 21, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

CN (1)