Relapse, difficult to treat, and multiple occurrences Sexual myeloma
Conditions
Interventions
Test group:Mitoxantrone liposomes+Pomalidomide+Dexamethasone
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meets the definition of relapsed and refractory myeloma; 2. Age range of 18-70 years old, male or female not limited; 3. There must be at least one of the following evaluable indicators: (1) Blood M protein level >= 10g/L; (2) 24-hour urinary M protein level >= 200mg; (3) The difference in free light chain between affected and non affected serum (dFLC) is >= 100mg/L; (4) The diameter of extramedullary lesions is greater than or equal to 2cm; 4. Eastern Oncology Collaborative Group Physical Fitness Score (ECOG): 0-2 points; 5. Expected survival period >= 3 months; 6. Blood routine: Neutrophil count >= 1 × 10^9/L; Platelets >= 100 × 10^9/L (if there is plasma in the bone marrow); Patients with cells= 75 × 10^9/L (patients with plasma cells in bone marrow >= 50%) (The person); Hemoglobin>8g/dL; 7. Liver and kidney function: serum creatinine <= 1.5 times the upper limit of normal value; AST and ALT <= 2.5 times positive;Upper limit of normal value (<= 5 times the upper limit of normal value for patients with liver invasion); Total bilirubin <= 1.5 times normal value;Upper limit (<= 3 times the normal upper limit for patients with liver invasion);
Exclusion criteria
Exclusion criteria: 1. Have hypersensitivity reactions to any research drug or its components; 2. Impaired heart function or significant heart disease, including but not limited to: a) Have experienced myocardial infarction or viral myocarditis within the 6 months prior to screening; b) When screening, there are heart diseases that require treatment, such as unstable angina and chronic congestive heart failure; Exhaustion (NYHA >= 2), arrhythmia, valve disease, or persistent cardiomyopathy; c) During screening, if the QTc interval is greater than 480ms or if the patient has long QTc syndrome; d) When screening, the ejection fraction of the heart is below 50% or below the lower limit of the examination range of the research center; 3. HBsAg or HBcAb positive and HBV-DNA titer higher than the lower limit of the detection value in the research center;Or HCV antibody positive and HCV-RNA titer higher than the lower limit of the research center's detection value, or HIV Antibody positive; 4. If the patient has a bacterial infection, fungal infection, or disease that requires systemic treatment within one week prior to drug administration Toxic infection; 5. Pregnant or breastfeeding women; 6. Grade 2 or above peripheral neuropathy or pain before treatment; 7. There are situations where other researchers have determined that it is not appropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS,progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Hematological and non hematological toxicity (NCI CTCAE v5.0);1-year progression free survival rate;1-year overall survival rate; | — |
Countries
China
Contacts
Public ContactLiu Jing
The Third Xiangya Hospital of Central South University
Outcome results
None listed