A Prospective, Open-label, Single-arm Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Daratumumab and Dexamethasone in the Treatment of Relapsed/Refractory Multiple Myeloma
A prospective, open-label, single-arm clinical study of mitoxantrone hydrochloride liposome injection combined with daratumumab and dexamethasone in the treatment of relapsed/refractory multiple myeloma
• 1\. Age :18-75 years, male or female; 2. Meet the definition of relapsed/refractory multiple myeloma; 3. At least one of the following can be evaluated:
‣ Blood M protein level ≥10g/L;
⁃ 24-hour urine M protein level ≥200mg;
⁃ The difference between involved and uninvolved serum free light chain (dFLC) ≥100mg/L;
⁃ Extramedullary lesions with a diameterday≥2cm; 4. ECOG score 0-2 points; 5. Laboratory tests meet the following criteria:
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‣ Absolute neutrophil count (ANC) ≥1.0x109/L;
⁃ Platelets (PLT) ≥50x109/L;
⁃ Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN;
⁃ Creatinine clearance rate (Ccr) ≥30ml/min.