multiple myeloma
Conditions
Interventions
research group. :VMD regimen based on mitoxantrone hydrochloride liposome injection.
Sponsors
First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. According to IMWG criteria, first diagnosed with multiple myeloma that requires immediate initiation of systemic treatment, with pathological and/or clinical diagnosis of extramedullary invasion; 2. Age: 18-70 years old; 3. Eastern Cooperative Oncology Group Physical fitness score (ECOG): 0-2 points; 4. Expected survival time = 3 months; 5. With "measurable lesions": extramedullary lesions ?1.0cm or more; 6. Blood routine: neutrophil count = 1.0×109/L; for patients with plasma cells >50% in bone marrow, 0.5×109/L=neutrophil count 50% are allowed 50×109/L = platelets 8g/dL; 7. Liver function: AST and ALT = (same age group) 2.5 times the upper limit of normal value, or =5 times the upper limit of normal value in the presence of liver metastasis; total bilirubin =1.5 times the upper limit of normal value; creatinine =2.5mg/dL; 8. Patients receiving local radiotherapy, regardless of whether Patients with concomitant steroids for pain management or spinal cord/nerve root compression treatment were eligible. More than 4 weeks from the date of the last radiotherapy; 9. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Impaired cardiac function or suffering from significant heart disease, including but not limited to: a) Myocardial infarction or viral myocarditis occurred within 6 months before screening; b) There is a heart disease that requires treatment at the time of screening. If not Stable angina, chronic congestive heart failure (NYHA = grade 2), arrhythmia, valvular disease, etc. or persistent cardiomyopathy; c) QTc interval >480ms at screening or long QTc syndrome; d) Heart disease at screening The ejection fraction is lower than 50% or lower than the lower limit of the examination value range of the research center. 2. Active infection of hepatitis B and hepatitis C (positive hepatitis B virus surface antigen and hepatitis B virus DNA exceeding 1x103 copies/mL; hepatitis C virus RNA exceeding 1x103 copies/mL); 3. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 4. Suffering from uncontrollable bacterial infection, fungal infection or viral infection that requires systemic treatment within 1 week before the administration of the study drug; 5. Women who are pregnant or breastfeeding; 6. Grade 2 (CTCAE5.0) or The above peripheral neuropathy or pain; 7. Received systemic chemotherapy within 28 days before the first medication; 8. There are situations where other researchers have determined that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year PFS rate.;2-year OS rate.;Safety; | — |
Countries
China
Contacts
Public ContactCai Zhen
First Affiliated Hospital of Zhejiang University School of Medicine.
Outcome results
None listed