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

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Monosialotetrahexosylganglioside
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring multiple myeloma, peripheral neuropathy, prophylaxis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Monosialotetrahexosylganglioside

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
complete rate (CR) rate
The criteria for CR was according to International Myeloma Working Group Uniform Response Criteria

Full Information

First Posted
March 13, 2014
Last Updated
November 17, 2014
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02093910
Brief Title
Efficacy of Monosialotetrahexosylganglioside in the Prophylactic Treatment of Bortezomib-induced Peripheral Neuropathy
Official Title
Phase 2 Study of Concurrent Monosialotetrahexosylganglioside in the Prophylactic Treatment of Bortezomib-induced Peripheral Neuropathy in Patients of Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, peripheral neuropathy, prophylaxis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monosialotetrahexosylganglioside
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Monosialotetrahexosylganglioside
Other Intervention Name(s)
bortezomib, dexamethasone
Primary Outcome Measure Information:
Title
overall incidence rate of peripheral neuropathy (PN)
Description
the grade of peripheral neuropathy (PN) was recorded according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
duration of peripheral neuropathy (PN)
Description
the duration of peripheral neuropathy means the time from the onset time of peripheral neuropathy (PN) to the relief time of PN
Time Frame
up to 1 year (about 6 months after the completion of treatment)
Title
complete rate (CR) rate
Description
The criteria for CR was according to International Myeloma Working Group Uniform Response Criteria
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong-jun Xia, M.D.
Phone
0086-020-87342438
Email
xiazhj@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Wang, M.D.
Phone
0086-020-87342439
Email
wangliang@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong-jun Xia, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Wang, M.D.
Phone
0086-02087342438
Email
wangliang@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Zhong-jun Xia, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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