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

IF 2.9 2区医学 Q2 ONCOLOGY

Cancer Medicine Pub Date : 2025-04-15 DOI:10.1002/cam4.70890

Ya-Lan Zhou, Jin-Qiao Zhang, Wei Wang, Li Bao, Bai-Jun Fang, Da Gao, Li-Ping Su, Wen-Ming Chen, Guang-Zhong Yang

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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%). 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

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来源期刊

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.