Mitoxantrone Hydrochloride Liposome Combination Regimen in the Treatment of High-risk/Extramedullary Multiple Myeloma

Phase 1

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Lipo-MIT combination regimen

• Registration Number: NCT06246162
• Lead Sponsor: Affiliated Hospital of Nantong University

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.

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-13
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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:

  2. Myocardial infarction or viral myocarditis occurred within 6 months before screening;

  3. 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;

  4. QTc interval >480ms or suffering from long QTc syndrome during screening;

  5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lipo-MIT combination regimen group	Lipo-MIT combination regimen	Initial diagnosis induction treatment regimen Lipo-MIT +VD (VMD): Mitoxantrone Hydrochloride Liposome: 10 mg, d1, d15, intravenous infusion; Bortezomib: 1.3mg/m2 d1, 4, 8, 11, subcutaneous injection; Dexamethasone: 20 mg/d, orally on days 1, 2, 4, 5, 8, 9, 11, and 12. Every 4 weeks constitutes a cycle, and 4 cycles of VMD regimen induction therapy are performed. Reinduction therapy regimen after relapse Lipo-MIT + PD (PMD): Mitoxantrone Hydrochloride Liposome: 10 mg, d1, d15, intravenous infusion; Pomalidomide: 4 mg/d d1-d21, orally; Dexamethasone: 20 mg/d, orally on days 1, 2, 4, 5, 8, 9, 11, and 12. Every 4 weeks constitutes a cycle, and 4 cycles of PMD regimen induction therapy are performed.

Primary Outcome Measures

Name	Time	Method
ORR	6 months	objective remission rate

Secondary Outcome Measures

Name	Time	Method
2-years PFS	2 years	2-years progression-free survival rate
TTNT	2 year	time to the next treatment
2-years extramedullary relapse rate	2 years	2-years extramedullary relapse rate
MRD negative conversion rate	6 months	minimal residual disease negative conversion rate
2-years OS	2 years	2-years overall survival rate
DoR	2 years	duration of response

Trial Locations

Locations (1)

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China