eligibility_summary
Eligible: adults 18-75 with relapsed/refractory MM, measurable disease (serum M >=10 g/L, 24-h urine M >=200 mg, dFLC >=100 mg/L, or extramedullary lesion >=2 cm), ECOG 0-2, labs: ANC >=1.0x10^9/L, PLT >=50x10^9/L, TBIL <=1.5xULN, AST/ALT <=2.5xULN, Ccr >=30 mL/min. Exclude: OS<3 mo, allergy to mitoxantrone/liposomal drugs, prior anthracycline >360 mg/m2, major cardiac disease/QTc>480 ms/EF<50%, active HBV/HCV/HIV, infection <1 wk, pregnant/lactating, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase 1/2 trial in relapsed/refractory multiple myeloma testing: 1) Mitoxantrone hydrochloride liposome: a liposomal anthracenedione chemotherapeutic that intercalates DNA and inhibits topoisomerase II, inducing DNA breaks, liposomal delivery enhances tumor uptake and may reduce cardiotoxicity. 2) Daratumumab: an anti-CD38 IgG1 monoclonal antibody mediating ADCC, CDC, ADCP, direct apoptosis, and immune modulation. 3) Dexamethasone: a glucocorticoid that is pro-apoptotic to lymphoid cells and anti-inflammatory. Targets/pathways: CD38+ malignant plasma cells, DNA replication/topoisomerase II, immune effector pathways (NK cells, macrophages, complement) and depletion of CD38+ immunosuppressive cells (Tregs/Bregs/MDSCs).