Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 문영철 | * |
dc.date.accessioned | 2019-08-22T16:30:09Z | - |
dc.date.available | 2019-08-22T16:30:09Z | - |
dc.date.issued | 2019 | * |
dc.identifier.issn | 1083-8791 | * |
dc.identifier.other | OAK-25227 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/251235 | - |
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. © 2019 American Society for Blood and Marrow Transplantation | * |
dc.language | English | * |
dc.publisher | Elsevier Inc. | * |
dc.subject | Autologous transplantation | * |
dc.subject | Bortezomib | * |
dc.subject | Busulfan | * |
dc.subject | Melphalan | * |
dc.subject | Myeloma | * |
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.relation.issue | 7 | * |
dc.relation.volume | 25 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.startpage | 1312 | * |
dc.relation.lastpage | 1319 | * |
dc.relation.journaltitle | Biology of Blood and Marrow Transplantation | * |
dc.identifier.doi | 10.1016/j.bbmt.2019.03.016 | * |
dc.identifier.wosid | WOS:000477092400005 | * |
dc.identifier.scopusid | 2-s2.0-85064497371 | * |
dc.author.google | Park S.-S. | * |
dc.author.google | Kim K. | * |
dc.author.google | Kim S.-J. | * |
dc.author.google | Lee J.H. | * |
dc.author.google | Yoon S.S. | * |
dc.author.google | Mun Y.C. | * |
dc.author.google | Lee J.-J. | * |
dc.author.google | Eom H.-S. | * |
dc.author.google | Kim J.S. | * |
dc.author.google | Min C.-K. | * |
dc.author.google | the Korean Multiple Myeloma Working Party | * |
dc.contributor.scopusid | 문영철(7003363716) | * |
dc.date.modifydate | 20240422115947 | * |