Treatment for high-risk multiple myeloma using a new drug combination

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of a combination regimen involving mitoxantrone hydrochloride liposome for patients diagnosed with high-risk or extramedullary multiple myeloma. The study will enroll approximately 30 participants aged 18 to 70 years, who will receive the treatment over a period from November 2023 to November 2026. The primary goal is to assess how well this new regimen works and its safety profile, with results expected to be published by the principal investigator.

Why it matters

Who can join: the full rules

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 \<1.0×109/L is allowed. For patients with platelets ≥100×109/L; plasma cells in bone marrow \>50%, 50×109/L≤platelets \<100×109/L; hemoglobin \>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

Where it's running

• Affiliated Hospital of Nantong University
  Nantong, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Hongming Huang, PhD
• Email: hhmmmc@163.com
• Phone: +8615006281688

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.