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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02093910
Recruitment Status : Unknown
Verified November 2014 by Xia Zhongjun, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : March 21, 2014
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):
Xia Zhongjun, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Monosialotetrahexosylganglioside Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase 2 Study of Concurrent Monosialotetrahexosylganglioside in the Prophylactic Treatment of Bortezomib-induced Peripheral Neuropathy in Patients of Multiple Myeloma
Study Start Date : April 2014
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Experimental: 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.
Drug: Monosialotetrahexosylganglioside
Other Names:
  • bortezomib
  • dexamethasone

Primary Outcome Measures :
  1. overall incidence rate of peripheral neuropathy (PN) [ Time Frame: up to 6 months ]
    the grade of peripheral neuropathy (PN) was recorded according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Secondary Outcome Measures :
  1. duration of peripheral neuropathy (PN) [ Time Frame: up to 1 year (about 6 months after the completion of treatment) ]
    the duration of peripheral neuropathy means the time from the onset time of peripheral neuropathy (PN) to the relief time of PN

  2. complete rate (CR) rate [ Time Frame: up to 6 months ]
    The criteria for CR was according to International Myeloma Working Group Uniform Response Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02093910

Contact: Zhong-jun Xia, M.D. 0086-020-87342438
Contact: Liang Wang, M.D. 0086-020-87342439

China, Guangdong
Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China, Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Liang Wang, M.D.    0086-02087342438   
Principal Investigator: Zhong-jun Xia, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Zhong-jun Xia, M.D. Sun Yat-sen University

Responsible Party: Xia Zhongjun, Professor, Sun Yat-sen University Identifier: NCT02093910     History of Changes
Other Study ID Numbers: GM1
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Xia Zhongjun, Sun Yat-sen University:
multiple myeloma
peripheral neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Peripheral Nervous System Agents
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neuromuscular Diseases
Nervous System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists