Trial record 12 of 1491 for:    Peripheral Neuropathy

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Xia Zhongjun, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02093910
First received: March 13, 2014
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: Monosialotetrahexosylganglioside
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • overall incidence rate of peripheral neuropathy (PN) [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: up to 1 year (about 6 months after the completion of treatment) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    The criteria for CR was according to International Myeloma Working Group Uniform Response Criteria


Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • monosialotetrahexosylganglioside

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02093910

Contacts
Contact: Zhong-jun Xia, M.D. 0086-020-87342438 xiazhj@sysucc.org.cn
Contact: Liang Wang, M.D. 0086-020-87342439 wangliang@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China, Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Liang Wang, M.D.    0086-02087342438    wangliang@sysucc.org.cn   
Principal Investigator: Zhong-jun Xia, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Zhong-jun Xia, M.D. Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Xia Zhongjun, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02093910     History of Changes
Other Study ID Numbers: GM1
Study First Received: March 13, 2014
Last Updated: March 19, 2014
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
multiple myeloma
peripheral neuropathy
prophylaxis

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Peripheral Nervous System Agents
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neuromuscular Diseases
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014