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Bortezomib-based induction followed by stem cell transplantation in light chain amyloidosis : results of the multicenter HOVON 104 trial

Monique C Minnema, Kazem Nasserinejad, Bouke Hazenberg, Ute Hegenbart, Philip Vlummens (UGent) , Paula F Ypma, Nicolaus Kroeger, Ka Lung Wu, Marie Jose Kersten, M Ron Schaafsma, et al.
(2019) HAEMATOLOGICA. 104(11). p.2274-2282
Author
Organization
Abstract
This prospective, multicenter, phase II study investigated the use of four cycles of bortezomib-dexamethasone induction treatment, followed by high-dose melphalan and autologous stem cell transplantation (SCT) in patients with newly diagnosed light chain amyloidosis. The aim of the study was to improve the hematologic complete remission (CR) rate 6 months after SCT from 30% to 50%. Fifty patients were enrolled and 72% had two or more organs involved. The overall hematologic response rate after induction treatment was 80% including 20% CR and 38% very good partial remissions (VGPR). Fifteen patients did not proceed to SCT for various reasons but mostly treatment-related toxicity and disease-related organ damage and death (2 patients). Thirty-one patients received melphalan 200 mg/m2 and four patients a reduced dose because of renal function impairment. There were no deaths related to the transplantation procedure. Hematologic responses improved at 6 months after SCT to 86% with 46% CR and 26% VGPR. However, due to the high treatment discontinuation rate before transplantation the primary endpoint of the study was not met and the CR rate in the intention-to-treat analysis was 32%. Organ responses continued to improve after SCT. We confirm the high efficacy of bortezomib-dexamethasone treatment in patients with AL amyloidosis. However, because of both treatment-related toxicity and disease characteristics, 30% of the patients could not proceed to SCT after induction treatment. (Trial registered at Dutch Trial Register identifier NTR3220).
Keywords
HIGH-DOSE MELPHALAN, SYSTEMIC AL AMYLOIDOSIS, HEMATOLOGIC RESPONSE, CARDIAC BIOMARKERS, STAGING SYSTEM, DEXAMETHASONE, THERAPY, BLOOD, CYCLOPHOSPHAMIDE, PROGRESSION

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MLA
Minnema, Monique C., et al. “Bortezomib-Based Induction Followed by Stem Cell Transplantation in Light Chain Amyloidosis : Results of the Multicenter HOVON 104 Trial.” HAEMATOLOGICA, vol. 104, no. 11, 2019, pp. 2274–82.
APA
Minnema, M. C., Nasserinejad, K., Hazenberg, B., Hegenbart, U., Vlummens, P., Ypma, P. F., … Schoenland, S. (2019). Bortezomib-based induction followed by stem cell transplantation in light chain amyloidosis : results of the multicenter HOVON 104 trial. HAEMATOLOGICA, 104(11), 2274–2282.
Chicago author-date
Minnema, Monique C, Kazem Nasserinejad, Bouke Hazenberg, Ute Hegenbart, Philip Vlummens, Paula F Ypma, Nicolaus Kroeger, et al. 2019. “Bortezomib-Based Induction Followed by Stem Cell Transplantation in Light Chain Amyloidosis : Results of the Multicenter HOVON 104 Trial.” HAEMATOLOGICA 104 (11): 2274–82.
Chicago author-date (all authors)
Minnema, Monique C, Kazem Nasserinejad, Bouke Hazenberg, Ute Hegenbart, Philip Vlummens, Paula F Ypma, Nicolaus Kroeger, Ka Lung Wu, Marie Jose Kersten, M Ron Schaafsma, Sandra Croockewit, Esther de Waal, Sonja Zweegman, Lidwien Tick, Annemieke Broijl, Harry Koene, Gerard Bos, Pieter Sonneveld, and Stefan Schoenland. 2019. “Bortezomib-Based Induction Followed by Stem Cell Transplantation in Light Chain Amyloidosis : Results of the Multicenter HOVON 104 Trial.” HAEMATOLOGICA 104 (11): 2274–2282.
Vancouver
1.
Minnema MC, Nasserinejad K, Hazenberg B, Hegenbart U, Vlummens P, Ypma PF, et al. Bortezomib-based induction followed by stem cell transplantation in light chain amyloidosis : results of the multicenter HOVON 104 trial. HAEMATOLOGICA. 2019;104(11):2274–82.
IEEE
[1]
M. C. Minnema et al., “Bortezomib-based induction followed by stem cell transplantation in light chain amyloidosis : results of the multicenter HOVON 104 trial,” HAEMATOLOGICA, vol. 104, no. 11, pp. 2274–2282, 2019.
@article{8647026,
  abstract     = {This prospective, multicenter, phase II study investigated the use of four cycles of bortezomib-dexamethasone induction treatment, followed by high-dose melphalan and autologous stem cell transplantation (SCT) in patients with newly diagnosed light chain amyloidosis. The aim of the study was to improve the hematologic complete remission (CR) rate 6 months after SCT from 30% to 50%. Fifty patients were enrolled and 72% had two or more organs involved. The overall hematologic response rate after induction treatment was 80% including 20% CR and 38% very good partial remissions (VGPR). Fifteen patients did not proceed to SCT for various reasons but mostly treatment-related toxicity and disease-related organ damage and death (2 patients). Thirty-one patients received melphalan 200 mg/m2 and four patients a reduced dose because of renal function impairment. There were no deaths related to the transplantation procedure. Hematologic responses improved at 6 months after SCT to 86% with 46% CR and 26% VGPR. However, due to the high treatment discontinuation rate before transplantation the primary endpoint of the study was not met and the CR rate in the intention-to-treat analysis was 32%. Organ responses continued to improve after SCT. We confirm the high efficacy of bortezomib-dexamethasone treatment in patients with AL amyloidosis. However, because of both treatment-related toxicity and disease characteristics, 30% of the patients could not proceed to SCT after induction treatment. (Trial registered at Dutch Trial Register identifier NTR3220).},
  author       = {Minnema, Monique C and Nasserinejad, Kazem and Hazenberg, Bouke and Hegenbart, Ute and Vlummens, Philip and Ypma, Paula F and Kroeger, Nicolaus and Wu, Ka Lung and Kersten, Marie Jose and Schaafsma, M Ron and Croockewit, Sandra and de Waal, Esther and Zweegman, Sonja and Tick, Lidwien and Broijl, Annemieke and Koene, Harry and Bos, Gerard and Sonneveld, Pieter and Schoenland, Stefan},
  issn         = {0390-6078},
  journal      = {HAEMATOLOGICA},
  keywords     = {HIGH-DOSE MELPHALAN,SYSTEMIC AL AMYLOIDOSIS,HEMATOLOGIC RESPONSE,CARDIAC BIOMARKERS,STAGING SYSTEM,DEXAMETHASONE,THERAPY,BLOOD,CYCLOPHOSPHAMIDE,PROGRESSION},
  language     = {eng},
  number       = {11},
  pages        = {2274--2282},
  title        = {Bortezomib-based induction followed by stem cell transplantation in light chain amyloidosis : results of the multicenter HOVON 104 trial},
  url          = {http://dx.doi.org/10.3324/haematol.2018.213900},
  volume       = {104},
  year         = {2019},
}
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