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

Multiple Myeloma Clinical Trial

Official title:

Mitoxantrone Hydrochloride Liposome Combination Regimen in the Treatment of High-risk/Extramedullary Multiple Myeloma:A Single-arm, Single-center, Prospective Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246162
• Other study ID #: 2023-TDFY-052
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 13, 2023
• Est. completion date: November 30, 2026

Study information

• Verified date: November 2023
• Source: Affiliated Hospital of Nantong University
• Contact: Hongming Huang, PhD
• Phone: +8615006281688
• Email: hhmmmc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	objective remission rate	6 months
Secondary	2-years PFS	2-years progression-free survival rate	2 years
Secondary	2-years OS	2-years overall survival rate	2 years
Secondary	2-years extramedullary relapse rate	2-years extramedullary relapse rate	2 years
Secondary	DoR	duration of response	2 years
Secondary	TTNT	time to the next treatment	2 year
Secondary	MRD negative conversion rate	minimal residual disease negative conversion rate	6 months