Treatment for relapsed/refractory multiple myeloma using mitoxantrone liposome injection

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

This study is testing a new treatment combining mitoxantrone liposome injection, daratumumab, and dexamethasone to see if it helps people with relapsed or refractory multiple myeloma feel better and live longer.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Soochow University (other)
• Drugs / interventions: doxorubicin, daratumumab
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05857982 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, open-label, single-arm study evaluating the efficacy of mitoxantrone hydrochloride liposome injection in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma. The study aims to enroll 20 patients who will receive the treatment over a maximum of six 4-week cycles, with dose adjustments based on patient tolerance. Participants will undergo a screening period followed by treatment and a two-year follow-up to assess safety and survival outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with relapsed or refractory multiple myeloma who meet specific laboratory and clinical criteria.

Not a fit: Patients with a life expectancy of less than three months or those with a history of allergy to mitoxantrone or liposomal drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed or refractory multiple myeloma.

How similar studies have performed: While this approach is novel in its specific combination, similar studies have shown promise in treating multiple myeloma with other therapies.

Eligibility 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.

Where this trial is running

Suzhou, Jiangsu

• Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Bingzong LI — Second Affiliated Hospital of Soochow University
• Study coordinator: Bingzong LI

Conditions: Relapsed/Refractory Multiple Myeloma