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Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma:a Nordic Myeloma Study Group randomized phase 3 trial
- Source :
- Mellqvist, U-H, Gimsing, P, Hjertner, O, Lenhoff, S, Laane, E, Remes, K, Steingrimsdottir, H, Abildgaard, N, Ahlberg, L, Blimark, C, Dahl, I M, Forsberg, K, Gedde-Dahl, T, Gregersen, H, Gruber, A, Guldbrandsen, N, Haukås, E, Carlson, K, Kvam, A K, Nahi, H, Lindås, R, Andersen, N F, Turesson, I, Waage, A, Westin, J & Nordic Myeloma Study Group 2013, ' Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma : a Nordic Myeloma Study Group randomized phase 3 trial ', Blood, vol. 121, no. 23, pp. 4647-54 . https://doi.org/10.1182/blood-2012-11-464503, Mellqvist, U-H, Gimsing, P, Hjertner, O, Lenhoff, S, Laane, E, Remes, K, Steingrimsdottir, H, Abildgaard, N, Ahlberg, L, Blimark, C, Dahl, I M, Forsberg, K, Gedde-Dahl, T, Gregersen, H E, Gruber, A, Guldbrandsen, N, Haukås, E, Carlson, K, Kvam, A K, Nahi, H, Lindås, R, Andersen, N F, Turesson, I, Waage, A, Westin, J & Nordic Myeloma Study Group 2013, ' Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma : a Nordic Myeloma Study Group randomized phase 3 trial ', Blood, vol. 121, no. 23, pp. 4647-4654 . https://doi.org/10.1182/blood-2012-11-464503, Mellqvist, U-H, Gimsing, P, Hjertner, O, Lenhoff, S, Laane, E, Remes, K, Steingrimsdottir, H, Abildgaard, N, Ahlberg, L, Blimark, C, Dahl, I M, Forsberg, K, Gedde-Dahl, T, Gregersen, H, Gruber, A, Guldbrandsen, N, Haukås, E, Carlson, K, Kvam, A K, Nahi, H, Lindås, R, Andersen, N F, Turesson, I, Waage, A, Westin, J & Nordic Myeloma Study Group 2013, ' Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma : a Nordic Myeloma Study Group randomized phase 3 trial ', Blood, vol. 121, no. 23, pp. 4647-4654 . https://doi.org/10.1182/blood-2012-11-464503
- Publication Year :
- 2013
-
Abstract
- The Nordic Myeloma Study Group conducted an open randomized trial to compare bortezomib as consolidation therapy given after high-dose therapy and autologous stem cell transplantation (ASCT) with no consolidation in bortezomib-naive patients with newly diagnosed multiple myeloma. Overall, 370 patients were centrally randomly assigned 3 months after ASCT to receive 20 doses of bortezomib given during 21 weeks or no consolidation. The hypothesis was that consolidation therapy would prolong progression-free survival (PFS). The PFS after randomization was 27 months for the bortezomib group compared with 20 months for the control group (P = .05). Fifty-one of 90 patients in the treatment group compared with 32 of 90 controls improved their response after randomization (P = .007). No difference in overall survival was seen. Fatigue was reported more commonly by the bortezomib-treated patients in self-reported quality-of-life (QOL) questionnaires, whereas no other major differences in QOL were recorded between the groups. Consolidation therapy seemed to be beneficial for patients not achieving at least a very good partial response (VGPR) but not for patients in the ≥ VGPR category at randomization. Consolidation with bortezomib after ASCT in bortezomib-naive patients improves PFS without interfering with QOL. This trial was registered at www.clinicaltrials.gov as #NCT00417911.
- Subjects :
- Oncology
Male
medicine.medical_specialty
Randomization
Clinical Trials and Observations
Immunology
Antineoplastic Agents
Biochemistry
Transplantation, Autologous
law.invention
Bortezomib
Autologous stem-cell transplantation
Randomized controlled trial
law
immune system diseases
Internal medicine
hemic and lymphatic diseases
medicine
Humans
cardiovascular diseases
Survival rate
neoplasms
Multiple myeloma
business.industry
Cell Biology
Hematology
Middle Aged
medicine.disease
Prognosis
Boronic Acids
Surgery
Clinical trial
Transplantation
Survival Rate
Pyrazines
Quality of Life
Female
Neoplasm Recurrence, Local
business
Multiple Myeloma
medicine.drug
Follow-Up Studies
Stem Cell Transplantation
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Mellqvist, U-H, Gimsing, P, Hjertner, O, Lenhoff, S, Laane, E, Remes, K, Steingrimsdottir, H, Abildgaard, N, Ahlberg, L, Blimark, C, Dahl, I M, Forsberg, K, Gedde-Dahl, T, Gregersen, H, Gruber, A, Guldbrandsen, N, Haukås, E, Carlson, K, Kvam, A K, Nahi, H, Lindås, R, Andersen, N F, Turesson, I, Waage, A, Westin, J & Nordic Myeloma Study Group 2013, ' Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma : a Nordic Myeloma Study Group randomized phase 3 trial ', Blood, vol. 121, no. 23, pp. 4647-54 . https://doi.org/10.1182/blood-2012-11-464503, Mellqvist, U-H, Gimsing, P, Hjertner, O, Lenhoff, S, Laane, E, Remes, K, Steingrimsdottir, H, Abildgaard, N, Ahlberg, L, Blimark, C, Dahl, I M, Forsberg, K, Gedde-Dahl, T, Gregersen, H E, Gruber, A, Guldbrandsen, N, Haukås, E, Carlson, K, Kvam, A K, Nahi, H, Lindås, R, Andersen, N F, Turesson, I, Waage, A, Westin, J & Nordic Myeloma Study Group 2013, ' Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma : a Nordic Myeloma Study Group randomized phase 3 trial ', Blood, vol. 121, no. 23, pp. 4647-4654 . https://doi.org/10.1182/blood-2012-11-464503, Mellqvist, U-H, Gimsing, P, Hjertner, O, Lenhoff, S, Laane, E, Remes, K, Steingrimsdottir, H, Abildgaard, N, Ahlberg, L, Blimark, C, Dahl, I M, Forsberg, K, Gedde-Dahl, T, Gregersen, H, Gruber, A, Guldbrandsen, N, Haukås, E, Carlson, K, Kvam, A K, Nahi, H, Lindås, R, Andersen, N F, Turesson, I, Waage, A, Westin, J & Nordic Myeloma Study Group 2013, ' Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma : a Nordic Myeloma Study Group randomized phase 3 trial ', Blood, vol. 121, no. 23, pp. 4647-4654 . https://doi.org/10.1182/blood-2012-11-464503
- Accession number :
- edsair.doi.dedup.....2302ea4b44dd559c126a70fc657dd8f3