CIPN
Conditions
Interventions
Sponsors
Harbin Institute of Hematology and Oncology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) The age ranged from 18 to 70 years (including both ends); 2) Patients diagnosed as active (symptomatic) multiple myeloma according to the Chinese guidelines for the diagnosis and treatment of multiple myeloma (MMM) in China (2017) are patients with initial diagnosis or treatment; 3) Patients who are expected to need VRD chemotherapy, or who have received 1-2 cycles of bortezomib based three drug combination chemotherapy regimens are initially diagnosed as active (symptomatic) multiple myeloma without neurotoxicity; 4) The expected survival time was more than 6 months; 5) ECoG score was 0-2; 6) Organ function level must meet the following requirements: Blood routine test: ANC >= 1.0 x 10^9 / L, PLT >= 50 x 10^9 / L; Liver function: TBIL = 50ml / min; Coagulation function: INR <= 1.5 x ULN; 7) Any toxicity associated with previous anti-tumor therapy must have recovered to <= 1 level (except for alopecia); 8) The results of serum or urine pregnancy test conducted by fertile female subjects within 7 days before the first use of the study drug must be negative; lactating women must agree to stop lactation before the first use of the study drug, and ensure that lactation is stopped during the study period. Female or male subjects of childbearing age agreed to take effective contraceptive measures during the clinical study until 6 months after the completion of administration; 9) Patients can accurately record the occurrence and severity of neurotoxicity questionnaire survey; 10) After the patients were enrolled in the trial, they were not allowed to accept any other treatment or nursing that might prevent or treat neurotoxic adverse reactions; 11) understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Inactive multiple myeloma, including MGUS and smoking myeloma; 2) Amyloidosis was found; 3) He had received more than 3 cycles of anti myeloma therapy; 4) There were more than 1 degree peripheral nervous system diseases before enrollment, as well as all other pathological symptoms or diseases that may affect the evaluation of neurotoxic adverse reactions; 5) History of stroke or cerebrovascular accident in the past 6 months; 6) Infectious diarrhea and craniocerebral trauma occurred within 4 weeks before screening; 7) Patients who had received major surgical treatment within 30 days before screening; 8) With uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before enrollment, grade III-IV heart failure as defined by the New York Heart Association (NYHA), uncontrolled angina pectoris, congestive heart failure, clinically significant pericardial disease or cardiac amyloidosis; 9) History of hereditary abnormal glucose and lipid metabolism (ganglioside accumulation disease, such as familial amaurosis dementia, retinal degeneration disease); 10) Syphilis screening positive, known HIV positive history or HIV screening positive, or HCV positive; 11) Patients with positive HBsAg and HBV-DNA > 2000iu / ml (or 104 copies / ml) in peripheral blood; 12) Known to have a clear history of neurological or mental disorders, including epilepsy, dementia, etc.; 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) It is planned to combine the use of peptides or protein mixtures, such as cerebroprotein hydrolysate, cerebroside myopeptide, deproteinized calf blood extract, etc.; other research drugs or test instruments that are not approved for marketing have been taken / used within three months before the study administration; 14) Those who have taken / used other research drugs not approved for marketing or participated in drug clinical trials within three months before drug administration (except those who have failed to participate in clinical trials of other research drugs and have not yet taken drugs, except those who can participate in the evaluation of researchers); 15) Other malignant tumors except multiple myeloma were found in 5 years before screening, except for carcinoma in situ or skin base / squamous carcinoma which were completely removed; 16) Known to be allergic to ganglioside lipids or to any excipient component of such products; or to chemotherapeutic drugs or to any excipient component of such products; 17) Patients who, in the judgment of the investigator, may increase the risk associated with the study, may interfere with the interpretation of the results of the study, or the investigator and / or the sponsor consider unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TNS; | — |
Countries
China
Contacts
Public ContactMa jun
Outcome results
None listed