Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed/Refractory Multiple Myeloma

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Soochow University
• Collaborator: The Affiliated Hospital of Xuzhou Medical University
• Treatments: Daratumumab; Dexamethasone; Mitoxantrone

Criteria

Inclusion Criteria:

• 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:

1. Blood M protein level ≥10g/L;

2. 24-hour urine M protein level ≥200mg;

3. The difference between involved and uninvolved serum free light chain (dFLC) ≥100mg/L;

4. Extramedullary lesions with a diameterday≥2cm; 4. ECOG score 0-2 points; 5. Laboratory tests meet the following criteria:

1. Absolute neutrophil count (ANC) ≥1.0x109/L;

2. Platelets (PLT) ≥50x109/L;

3. Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);

4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN;

5. Creatinine clearance rate (Ccr) ≥30ml/min.

Exclusion Criteria:

• 1.Expected survival time <3 months. 2.History of allergy to mitoxantrone or liposomal drugs; previous treatment with mitoxantrone or other anthracycline therapy, total cumulative dose of mitoxantrone >360 mg/m2 (other anthracycline drugs are equivalent to 1mg mitoxantrone, 2mg doxorubicin or 0.5mg epirubicin).

3.Impaired cardiac function or significant heart disease, including but not limited to: a) Myocardial infarction or viral myocarditis within 6 months before screening. b) Existing heart disease requiring treatment at the time of screening, such as unstable angina pectoris, chronic congestive heart failure (NYHA≥2), arrhythmia, valve disease, etc., or persistent myocardial disease. c) QTc interval>480ms at screening or long QTc syndrome. d) Ejection fraction less than 50% at screening or lower than the lower limit of the study center's examination value range.

4.HBsAg or HBcAb positive and HBV-DNA titer higher than the lower limit of the study center's detection value, or HCV antibody positive and HCV-RNA titer higher than the lower limit of the study center's detection value, or HIV antibody positive.

5.Bacterial infection, fungal infection or viral infection requiring systemic treatment within 1 week before administration of the study drug.

6.Pregnant or lactating women. 7.Other situations judged by investigator as inappropriate for participation in this study.