Cited 9 times in
A Phase I/II, Open-Label, Prospective, Multicenter Study to Evaluate the Efficacy and Safety of Lower Doses of Bortezomib Plus Busulfan and Melphalan as a Conditioning Regimen in Patients with Multiple Myeloma Undergoing Autologous Peripheral Blood Stem Cell Transplantation: The KMM103 Study
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 김진석 | - |
dc.date.accessioned | 2019-12-18T00:36:07Z | - |
dc.date.available | 2019-12-18T00:36:07Z | - |
dc.date.issued | 2019 | - |
dc.identifier.issn | 1083-8791 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/173131 | - |
dc.description.abstract | A phase I/II trial was conducted to explore the safety and activity of the addition of bortezomib on days -6, -3, and +1 relative to the day of autologous stem cell transplantation (ASCT) to a conditioning regimen with busulfan and melphalan (BuMel; 3.2 mg/kg/day busulfan on days -5 to -3 and 140 mg/m2/day melphalan on day -2) in patients with multiple myeloma (MM) following bortezomib-based induction chemotherapy. In phase I, doses of bortezomib (.7, 1.0, and 1.3 mg/m2) with BuMel were administered to groups of 3 patients each. No dose-limiting toxicities were observed. The maximum tolerated dose of bortezomib was 1.3 mg/m2/day. A subsequent cohort with 41 patients was analyzed in a phase II trial to identify safety and efficacy. The phase II trial showed a 75% response rate, including very good partial response (VGPR) or better, and a 55% rate of complete response (CR) at 3 months; For post-transplantation best response, an 83% rate of VGPR or better (68% CR) was observed. With a median follow-up of 31.4 months, the median progression-free survival (PFS) was 26.8 months. The probability of 2 year-PFS was 56.5%, and median overall survival (OS) could not calculated. Specifically, high-risk cytogenetics were associated with adverse survival outcomes compared with standard-risk cytogenetics (median PFS, 12.2 months versus 35.7 months, P = .039; median OS, 26.7 months versus 73.3 months; P = .086). With a median of 11 days to neutrophil engraftment and 10 days for platelet engraftment, no graft failure or delayed engrafting were observed. The most common grade 3 or severe nonhematologic adverse events included neutropenic fever (73.2%) and stomatitis (14.6%). Except for 3 patients with transplantation-related mortality due to sepsis, other adverse events were manageable. These findings demonstrate that bortezomib is safe and has a potential role in conditioning regimens in combination with BuMel for patients with transplantation-eligible MM. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Carden Jennings Publishing | - |
dc.relation.isPartOf | BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | A Phase I/II, Open-Label, Prospective, Multicenter Study to Evaluate the Efficacy and Safety of Lower Doses of Bortezomib Plus Busulfan and Melphalan as a Conditioning Regimen in Patients with Multiple Myeloma Undergoing Autologous Peripheral Blood Stem Cell Transplantation: The KMM103 Study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Sung-Soo Park | - |
dc.contributor.googleauthor | Kihyun Kim | - |
dc.contributor.googleauthor | Seok-Jin Kim | - |
dc.contributor.googleauthor | Jae Hoon Lee | - |
dc.contributor.googleauthor | Sung Soo Yoon | - |
dc.contributor.googleauthor | Yeung Chul Mun | - |
dc.contributor.googleauthor | Je-Jung Lee | - |
dc.contributor.googleauthor | Hyeon-Seok Eom | - |
dc.contributor.googleauthor | Jin Seok Kim | - |
dc.contributor.googleauthor | Chang-Ki Min | - |
dc.identifier.doi | 10.1016/j.bbmt.2019.03.016 | - |
dc.contributor.localId | A01017 | - |
dc.relation.journalcode | J00308 | - |
dc.identifier.eissn | 1523-6536 | - |
dc.identifier.pmid | 30910603 | - |
dc.identifier.url | https://www.sciencedirect.com/science/article/pii/S1083879119301922 | - |
dc.subject.keyword | Autologous transplantation | - |
dc.subject.keyword | Bortezomib | - |
dc.subject.keyword | Busulfan Melphalan | - |
dc.subject.keyword | Myeloma | - |
dc.contributor.alternativeName | Kim, Jin Seok | - |
dc.contributor.affiliatedAuthor | 김진석 | - |
dc.citation.volume | 25 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 1312 | - |
dc.citation.endPage | 1319 | - |
dc.identifier.bibliographicCitation | BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION, Vol.25(7) : 1312-1319, 2019 | - |
dc.identifier.rimsid | 64090 | - |
dc.type.rims | ART | - |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.