دورية أكاديمية
Phase II clinical trial for the evaluation of bortezomib within the reduced intensity conditioning regimen (RIC) and post-allogeneic transplantation for high-risk myeloma patients
| العنوان: | Phase II clinical trial for the evaluation of bortezomib within the reduced intensity conditioning regimen (RIC) and post-allogeneic transplantation for high-risk myeloma patients |
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| المؤلفون: | Caballero-Velázquez, Teresa, López-Corral, L., Encinas, Cristina, Caballero, Maria Dolores, San Miguel, Jesús F., Pérez-Simón, José A. |
| المساهمون: | Ministerio de Sanidad y Política Social (España), Instituto de Salud Carlos III |
| بيانات النشر: | John Wiley & Sons |
| سنة النشر: | 2013 |
| المجموعة: | Digital.CSIC (Consejo Superior de Investigaciones Científicas / Spanish National Research Council) |
| مصطلحات موضوعية: | Transplantation, Conditioning regimen, Graft-versus-host disease, Bortezomib, Multiple myeloma |
| الوصف: | The current study was designed to assess the safety and efficacy of bortezomib in combination with fludarabine and melphalan as reduced intensity conditioning before allogeneic stem cell transplantation in patients with high risk multiple myeloma. Sixteen patients were evaluable. The median number of previous line of treatment was 3; all patients had relapsed following a prior autograft and 13 had previously received bortezomib. Fifteen of them either remained stable or improved disease status at day +100 post-transplant, including 11 patients with active disease. More specifically, nine patients (56%) and five patients (31%) reached complete remission and partial response, respectively. 25% developed grade III acute graft-versus-host disease. The cumulative incidence of non-relapse mortality, relapse and overall survival were 25%, 54% and 41%, respectively, at 3 years. Regarding the non-haematological toxicity (grade>2), two patients developed peripheral neuropathy, two patients liver toxicity and 1 pulmonary toxicity early post-transplant. The haematological toxicity was only observed during the first three cycles mostly related to low haemoglobin and platelet levels. The current trial is the first one evaluating the safety and efficacy of bortezomib as part of a reduced intensity conditioning regimen among patients with high risk multiple myeloma. ; This study was partially supported by a grant from the Ministery of Health (EC10-289); Teresa Caballero was supported by a grant Rio Hortega (code: CM10/00161) from the Instituto de Salud Carlos III. The study was supported by Jassen-Cilaj providing bortezomib free of charge as well as financial support. ; Peer Reviewed |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| تدمد: | 0007-1048 |
| العلاقة: | Sí; e-issn: 1365-2141; British Journal of Haematology 162(4): 474-482 (2013); http://hdl.handle.net/10261/134495Test; http://dx.doi.org/10.13039/501100004587Test |
| DOI: | 10.1111/bjh.12410 |
| DOI: | 10.13039/501100004587 |
| الإتاحة: | https://doi.org/10.1111/bjh.12410Test https://doi.org/10.13039/501100004587Test http://hdl.handle.net/10261/134495Test |
| حقوق: | none |
| رقم الانضمام: | edsbas.764765E6 |
| قاعدة البيانات: | BASE |
| تدمد: | 00071048 |
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| DOI: | 10.1111/bjh.12410 |