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

November 17, 2014 updated by: Xia Zhongjun, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,
        • Principal Investigator:
          • Zhong-jun Xia, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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:
  • dexamethasone
  • bortezomib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 year (about 6 months after the completion of treatment)
complete rate (CR) rate
Time Frame: up to 6 months
The criteria for CR was according to International Myeloma Working Group Uniform Response Criteria
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Zhong-jun Xia, M.D., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GM1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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