NCT06246162

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-13
• Primary completion: 2025-11-30
• Completion: 2026-11-30
• First posted: 2024-02-07
• Last updated: 2024-02-07

Locations

1 site across 1 country: China