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

• Published in: Cancer medicine (Malden, MA) Vol. 14; no. 8; pp. e70890 - n/a
• Main Authors: Zhou, Ya‐Lan, Zhang, Jin‐Qiao, Wang, Wei, Bao, Li, Fang, Bai‐Jun, Gao, Da, Su, Li‐Ping, Chen, Wen‐Ming, Yang, Guang‐Zhong
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.04.2025; John Wiley and Sons Inc; Wiley
• Subjects: Adult; Aged; Anthracycline; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bortezomib; Bortezomib - administration & dosage; Bortezomib - adverse effects; Cell cycle; Clinical trials; Dexamethasone; Dexamethasone - administration & dosage; Dexamethasone - adverse effects; Drug Resistance, Neoplasm; efficacy; Female; Humans; Leukemia; Liposomes; Lymphopenia; Male; Middle Aged; Mitoxantrone; Mitoxantrone - administration & dosage; Mitoxantrone - adverse effects; mitoxantrone hydrochloride liposome; Multiple myeloma; Multiple Myeloma - drug therapy; Multiple Myeloma - pathology; Neutropenia; Proteasome inhibitors; Proteasomes; relapsed/refractory multiple myeloma; Remission (Medicine); Response rates; safety; Thrombocytopenia; Toxicity; Treatment Outcome; relapsed/refractory multiple myeloma; mitoxantrone hydrochloride liposome; safety; efficacy
• ISSN: 2045-7634; 2045-7634
• DOI: 10.1002/cam4.70890

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