Clinical trial NCT06246162: Mitoxantrone Hydrochloride Liposome Combination Regimen in the Treatment of High-risk/Extramedullary Multiple Myeloma
Official title: Mitoxantrone Hydrochloride Liposome Combination Regimen in the Treatment of High-risk/Extramedullary Multiple Myeloma:A Single-arm, Single-center, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of mitoxantrone Hydrochloride Hydrochloride Liposome combination regimen in the treatment of high-risk/extramedullary multiple myeloma

Detailed description: This study is expected to be carried out from November 2023 to November 2026. About 30 patients with high-risk/extramedullary multiple myeloma will receive mitoxantrone Hydrochloride Liposome combination regimen treatment. After evaluating of efficacy and safety of treatment, the principal investigator will write and publish the paper.

Eligibility criteria: 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

Primary outcomes:
measure: ORR
timeFrame: 6 months
Secondary outcomes:
measure: 2-years PFS
timeFrame: 2 years
measure: 2-years OS
timeFrame: 2 years
measure: 2-years extramedullary relapse rate
timeFrame: 2 years
measure: DoR
timeFrame: 2 years
measure: TTNT
timeFrame: 2 year
measure: MRD negative conversion rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Hongming Huang, PhD
role: STUDY_DIRECTOR
References: