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...
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Wiley
2025-04-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.70890 |
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| author | Ya‐Lan Zhou Jin‐Qiao Zhang Wei Wang Li Bao Bai‐Jun Fang Da Gao Li‐Ping Su Wen‐Ming Chen Guang‐Zhong Yang |
| author_facet | Ya‐Lan Zhou Jin‐Qiao Zhang Wei Wang Li Bao Bai‐Jun Fang Da Gao Li‐Ping Su Wen‐Ming Chen Guang‐Zhong Yang |
| author_sort | Ya‐Lan Zhou |
| collection | DOAJ |
| description | 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 |
| format | Article |
| id | doaj-art-0ccacd30c0254a27a492c8d55e549294 |
| institution | OA Journals |
| issn | 2045-7634 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj-art-0ccacd30c0254a27a492c8d55e5492942025-08-20T02:24:54ZengWileyCancer Medicine2045-76342025-04-01148n/an/a10.1002/cam4.70890Bortezomib, Mitoxantrone Hydrochloride Liposome, and Dexamethasone for Relapsed/Refractory Multiple Myeloma: A Multi‐Center, Open‐Label Phase I TrialYa‐Lan Zhou0Jin‐Qiao Zhang1Wei Wang2Li Bao3Bai‐Jun Fang4Da Gao5Li‐Ping Su6Wen‐Ming Chen7Guang‐Zhong Yang8Department of Hematology, Beijing Chaoyang Hospital Capital Medical University Beijing ChinaDepartment of Hematology The Third Hospital of Hebei Medical University Hebei ChinaDepartment of Hematology The Second Affiliated Hospital of Harbin Medical University Heilongjiang ChinaDepartment of Hematology, Beijing Jishuitan Hospital Capital Medical University Beijing ChinaDepartment of Hematology Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital Henan ChinaDepartment of Hematology Affiliated Hospital of Inner Mongolia Medical University Inner Mongolia ChinaDepartment of Hematology Shanxi Provincial Cancer Hospital Shanxi ChinaDepartment of Hematology, Beijing Chaoyang Hospital Capital Medical University Beijing ChinaDepartment of Hematology, Beijing Chaoyang Hospital Capital Medical University Beijing ChinaABSTRACT 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: NCT05052970https://doi.org/10.1002/cam4.70890efficacymitoxantrone hydrochloride liposomerelapsed/refractory multiple myelomasafety |
| spellingShingle | Ya‐Lan Zhou Jin‐Qiao Zhang Wei Wang Li Bao Bai‐Jun Fang Da Gao Li‐Ping Su Wen‐Ming Chen Guang‐Zhong Yang Bortezomib, Mitoxantrone Hydrochloride Liposome, and Dexamethasone for Relapsed/Refractory Multiple Myeloma: A Multi‐Center, Open‐Label Phase I Trial Cancer Medicine efficacy mitoxantrone hydrochloride liposome relapsed/refractory multiple myeloma safety |
| title | Bortezomib, Mitoxantrone Hydrochloride Liposome, and Dexamethasone for Relapsed/Refractory Multiple Myeloma: A Multi‐Center, Open‐Label Phase I Trial |
| title_full | Bortezomib, Mitoxantrone Hydrochloride Liposome, and Dexamethasone for Relapsed/Refractory Multiple Myeloma: A Multi‐Center, Open‐Label Phase I Trial |
| title_fullStr | Bortezomib, Mitoxantrone Hydrochloride Liposome, and Dexamethasone for Relapsed/Refractory Multiple Myeloma: A Multi‐Center, Open‐Label Phase I Trial |
| title_full_unstemmed | Bortezomib, Mitoxantrone Hydrochloride Liposome, and Dexamethasone for Relapsed/Refractory Multiple Myeloma: A Multi‐Center, Open‐Label Phase I Trial |
| title_short | Bortezomib, Mitoxantrone Hydrochloride Liposome, and Dexamethasone for Relapsed/Refractory Multiple Myeloma: A Multi‐Center, Open‐Label Phase I Trial |
| title_sort | bortezomib mitoxantrone hydrochloride liposome and dexamethasone for relapsed refractory multiple myeloma a multi center open label phase i trial |
| topic | efficacy mitoxantrone hydrochloride liposome relapsed/refractory multiple myeloma safety |
| url | https://doi.org/10.1002/cam4.70890 |
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