Clinical trial NCT02093910: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: multiple myeloma
peripheral neuropathy
prophylaxis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: overall incidence rate of peripheral neuropathy (PN)
timeFrame: up to 6 months
Secondary outcomes:
measure: duration of peripheral neuropathy (PN)
timeFrame: up to 1 year (about 6 months after the completion of treatment)
measure: complete rate (CR) rate
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhong-jun Xia, M.D.
role: PRINCIPAL_INVESTIGATOR
References: