CIPN
Conditions
Interventions
Group 1:GM1 100mg/d
Group 2:GM1 200mg/d
Group 3:GM1 400mg/d
Group 4 :Nil
Sponsors
Harbin Institute of Hematology and Oncology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-70 years old (including both ends); 2) According to the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (2017), patients who are diagnosed as active (symptomatic) multiple myeloma and are newly diagnosed or treated; 3) Patients who are expected to use VRD chemotherapy regimen for chemotherapy; or patients who have undergone 1-2 cycles of bortezomib as the main 3-drug combined chemotherapy regimen for chemotherapy for the first time are diagnosed as active (symptomatic) multiple myeloma patients, and no Neurotoxicity; 4) The expected survival period is >= 6 months; 5) ECOG score 0-2 points; 6) The organ function level must meet the following requirements: Blood routine: ANC >= 1.0 x 10^9/L, PLT >= 50 x 10^9/L; Liver function: TBIL = 50ml/min; Coagulation function: International Normalized Ratio (INR) <= 1.5 x ULN; 7) Any toxicity related to previous anti-tumor treatments must have been restored to <= 1 grade (except for hair loss); 8) Female subjects with childbearing potential should undergo a serum or urine pregnancy test within 7 days before using the study drug for the first time, and the result must be negative; breastfeeding women must agree to stop breastfeeding before using the study drug for the first time, and guarantee to stop during the study breast-feeding. Female or male subjects of childbearing age agree to take effective contraceptive measures during the clinical study until 6 months after the completion of the administration; 9) Questionnaire survey in which patients can accurately record the occurrence and severity of neurotoxicity; 10) After the patient is enrolled in the trial, he cannot accept other treatments or care that may prevent or treat neurotoxic adverse reactions; 11) Understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Inactive multiple myeloma, including MGUS (unqualified monoclonal immunoglobulin disease) and smoking myeloma; 2) Combined amyloidosis; 3) Have received anti-myeloma treatment for >= 3 cycles of chemotherapy; 4) Peripheral nervous system diseases with >= 1 degree before enrollment, and all other pathological symptoms or diseases that may affect the evaluation of neurotoxic adverse reactions; 5) Have a history of stroke or cerebrovascular accident in the past 6 months; 6) Infectious diarrhea and craniocerebral trauma diseases occurred within 4 weeks before screening; 7) Those who have received major surgery within 30 days before screening; 8) Uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before enrollment, grade III-IV heart failure defined by the New York College of Cardiology (NYHA), uncontrolled angina, and congestive Heart failure, clinically significant pericardial disease or cardiac amyloidosis; 9) History of inherited abnormal glucose and lipid metabolism (ganglioside accumulation disease, such as: familial amaurian dementia, retinal degeneration); 10) Positive syphilis screening, known HIV-positive medical history or HIV screening-positive, or HCV-positive; 11) Hepatitis B surface antigen (HBsAg) is positive, and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA)>2000IU/ml (or 104 copies/ml); 12) A known history of neurological or mental disorders, including epilepsy, dementia, etc.; pre-existing gods Degenerative diseases (Parkinson's disease, Alzheimer's disease, Huntington's disease, etc.) or neuromuscular diseases (multiple sclerosis, amyotrophic lateral sclerosis, poliomyelitis, tuberculous encephalitis, hereditary neuromuscular diseases) ); 13) Plan to combine the use of peptides or protein mixtures, such as brain protein hydrolysate, cerebroside carnosine, calf blood deproteinized extract, etc.; have taken/used other research drugs that have not been approved for marketing within three months before the study administration Test equipment; 14) Those who have taken/used other research drugs that have not been approved for marketing within three months before the study administration, or participated in the drug clinical trials (participating in the clinical trials of other research drugs failed, and those who have not yet used the drug can participate after the researchers evaluation Except those); 15) Suffered from other malignant tumors other than multiple myeloma within 5 years before screening, except for completely resected carcinoma in situ or skin base/squamous carcinoma; 16) Known allergy to ganglioside drugs or any excipient components of such products; or allergy to chemotherapy drugs or any excipient components of such products; 17) According to the judgment of the investigator, patients who may increase the risk related to the study, may interfere with the interpretation of the study results, or the investigator and/or the sponsor deems unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TNS; | — |
Countries
China
Contacts
Public ContactMa Jun
Harbin Institute of Hematology and Oncology
Outcome results
None listed