Bortezomib, Mitoxantrone Hydrochloride Liposome, and Dexamethasone for Relapsed/Refractory Multiple Myeloma: A Multi-Center, Open-Label Phase I Trial.

ABSTRACT:

Backgrounds

Mitoxantrone hydrochloride liposome (Lipo-MIT) has shown clinical benefits in various tumors. However, there is no prospective study evaluating its effectiveness and safety in relapsed/refractory multiple myeloma (RRMM). A phase I trial of bortezomib, Lipo-MIT, and dexamethasone (VMitD) with the primary endpoints being safety and efficacy was performed.

Methods

Twenty subjects were enrolled this study, and the dose of Lipo-MIT was designed to be 12, 16, and 20 mg/m² at Day 1 combined with bortezomib and dexamethasone.

Results

The most common grade 3/4 non-hematologic adverse event was pneumonia (20%). The most frequently observed grade 3/4 hematologic toxicity included thrombocytopenia (70%), neutropenia (55%), lymphopenia (30%), and anemia (10%

SUBMITTER: Zhou YL 

PROVIDER: S-EPMC11998603 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature