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

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%). Fifteen subjects received at least one efficacy evaluation, including 60% (9/15) with a very good partial response (VGPR) or better, resulting in an overall response rate (ORR) of 86.7% (13/15).

CONCLUSIONS

This is the first report about the novel triplet regimen VMitD, including Lipo-MIT for RRMM, which was well tolerated and demonstrated efficacy. Further studies are required to assess the outcomes more accurately and to evaluate its effectiveness in comparison to other salvage regimens containing proteasome inhibitors and anthracyclines.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05052970.