mitoxantrone hydrochloride liposome combination regimen in the treatment of high-risk/extramedullary multiple myeloma

Conditions: Multiple Myeloma

Summary: to evaluate the efficacy and safety of mitoxantrone hydrochloride hydrochloride liposome combination regimen in the treatment of high-risk/extramedullary multiple myeloma

this study is expected to be carried out from november 2023 to november 2026. about 30 patients with high-risk/extramedullary multiple myeloma will receive mitoxantrone hydrochloride liposome combination regimen treatment. after evaluating of efficacy and safety of treatment, the principal investigator will write and publish the paper.

Eligibility criteria:
inclusion criteria: * 1. diagnosed with high-risk multiple myeloma (del17p, t (4; 14), t (14; 16), 1q21 by fish test) or extramedullary multiple myeloma; 2. age: 18-70 years old (including 18 and 70 years old), regardless of gender; 3. eastern cooperative oncology group physical performance score (ecog): 0-2 points; 4. expected survival ≥3 months; 5. have "measurable lesions": extramedullary lesions ≧1.0cm or more; serum m protein ≥10g/l and/or 24-hour urine m protein ≥200mg; 6. blood routine: neutrophil count ≥1.0×109/l; for patients with plasma cells in bone marrow \>50%, 0.5×109/l≤neutrophil count \ 50%, 50×109/l≤platelets \ 8g/dl; 7. liver function: ast and alt ≤ 2.5 times the upper limit of normal value (for the same age group), 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 ≤ 2.5 mg/dl ; 8. patients receiving localized radiation therapy, with or without concomitant steroids, for pain control or spinal cord/nerve root compression treatment are eligible. more than 4 weeks since the last radiotherapy treatment; 9. sign the informed consent form. exclusion criteria: * 1. impaired heart function or suffering from significant heart disease, including but not limited to: 1. myocardial infarction or viral myocarditis occurred within 6 months before screening; 2. there are heart diseases that require treatment at the time of screening, such as unstable angina, chronic congestive heart failure (nyha ≥ grade 2), arrhythmia, valvular disease, etc. or persistent cardiomyopathy; 3. qtc interval \>480ms or suffering from long qtc syndrome during screening; 4. the cardiac ejection fraction is lower than 50% or lower than the lower limit of the examination value range of the research center during screening. 2. active infection of hepatitis b and hepatitis c (hepatitis b virus surface antigen is positive and hepatitis b virus dna exceeds 1x103 copies/ml; hepatitis c virus rna exceeds 1x103 copies/ml); 3. human immunodeficiency virus (hiv) infection (hiv antibody positive); 4. suffer 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. peripheral neuropathy or pain of grade 2 (ctcae5.0) or above before treatment; 7. received systemic chemotherapy within 28 days before the first dose; 8. relapsed patients are resistant to pomalidomide in previous treatment or cannot accept pomalidomide treatment