NCT05857982

Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed/Refractory Multiple Myeloma

A Prospective, Open-label, Single-arm Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Daratumumab and Dexamethasone in the Treatment of Relapsed/Refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A prospective, open-label, single-arm clinical study of mitoxantrone hydrochloride liposome injection combined with daratumumab and dexamethasone in the treatment of relapsed/refractory multiple myeloma

Detailed description

This study is a prospective, open-label, single-arm study. It is expected to include 20 patients with relapsed/refractory multiple myeloma who will receive combined treatment. The recommended dose of mitoxantrone hydrochloride liposome injection is 20mg/m2 (the dose can be adjusted according to the patient's tolerance, but the minimum dose is not less than 12mg/m2). Each cycle is 4 weeks long and the maximum number of cycles is 6. Dexamethasone 20 mg/d, on the same day of daratumumab injection; Mitoxantrone hydrochloride liposome injection: 20 mg/m2, d1; Daratumumab: 16 mg/Kg, once a week for the first 8 weeks; then changed to once every two weeks; The study includes a screening period (within 28 days), a treatment period (up to 6 cycles), and a follow-up period (safety follow-up, survival follow-up, planned for 2 years). The subjects signed an informed consent form and underwent baseline examination during the screening period. Eligible patients were enrolled in the treatment period. All subjects underwent relevant examinations as stipulated in the protocol during the treatment process to observe efficacy and safety. After the treatment period ends, they will enter the follow-up period.

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab	Dexamethasone 20 mg/d, on the same day of daratumumab injection; Mitoxantrone hydrochloride liposome injection: 20 mg/m2, d1; Daratumumab: 16 mg/Kg, once a week for the first 8 weeks; then changed to once every two weeks; Each cycle is 4 weeks long and the maximum number of cycles is 6.

Timeline

• Start date: 2023-05-20
• Primary completion: 2025-01-31
• Completion: 2025-12-31
• First posted: 2023-05-15
• Last updated: 2023-05-15

Locations

1 site across 1 country: China