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Efficacy and Safety of a Weekly Cyclophosphamide-Bortezomib-Dexamethasone Regimen as Induction Therapy Prior to Autologous Stem Cell Transplantation in Japanese Patients with Newly Diagnosed Multiple Myeloma: A Phase 2 Multicenter Trial

Efficacy and Safety of a Weekly Cyclophosphamide-Bortezomib-Dexamethasone Regimen as Induction... We assessed the efficacy and safety of weekly cyclophosphamide-bortezomib-dexamethasone (CBD) induction prior to autologous stem cell transplantation (ASCT) in newly diagnosed Japanese patients with multiple myeloma (MM). This regimen consisted of four 28-day cycles of once-weekly oral cyclophosphamide (300 mg/m<sup>2</sup>), subcutaneous bortezomib (1.3 mg/m<sup>2</sup>), and oral dexamethasone (40 mg). Responding patients underwent stem cell collection followed by ASCT. The primary endpoint was the postinduction rate of achieving a near complete response (nCR) or better. Among the 38 enrolled patients, a complete response (CR), an nCR, a very good partial response (VGPR), and a partial response (PR) were achieved in 10.5, 2.6, 23.7, and 36.8% of cases, respectively. A grade 4 hematological adverse event (AE) was observed in 1 patient. Grade 3–4 infection, including febrile neutropenia, was observed in 4 patients (10.5%). Although 2 patients dropped out due to AE, 94.7% of the patients completed the induction phase. However, because of a poor response to induction chemotherapy (<PR in 6 patients), poor stem cell mobilization (4 patients), and a protocol violation (1 patient), only 24 patients (63.2%) proceeded to ASCT. The 2-year progression-free and overall survivals were 55.3 and 82.7%, respectively. We thus believe that the therapeutic power of weekly CBD is not strong enough as a 3-drug induction regimen despite its feasibility for most Japanese patients. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Acta Haematologica Karger

Efficacy and Safety of a Weekly Cyclophosphamide-Bortezomib-Dexamethasone Regimen as Induction Therapy Prior to Autologous Stem Cell Transplantation in Japanese Patients with Newly Diagnosed Multiple Myeloma: A Phase 2 Multicenter Trial

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Publisher
Karger
Copyright
© 2019 S. Karger AG, Basel
ISSN
0001-5792
eISSN
1421-9662
DOI
10.1159/000495338
Publisher site
See Article on Publisher Site

Abstract

We assessed the efficacy and safety of weekly cyclophosphamide-bortezomib-dexamethasone (CBD) induction prior to autologous stem cell transplantation (ASCT) in newly diagnosed Japanese patients with multiple myeloma (MM). This regimen consisted of four 28-day cycles of once-weekly oral cyclophosphamide (300 mg/m<sup>2</sup>), subcutaneous bortezomib (1.3 mg/m<sup>2</sup>), and oral dexamethasone (40 mg). Responding patients underwent stem cell collection followed by ASCT. The primary endpoint was the postinduction rate of achieving a near complete response (nCR) or better. Among the 38 enrolled patients, a complete response (CR), an nCR, a very good partial response (VGPR), and a partial response (PR) were achieved in 10.5, 2.6, 23.7, and 36.8% of cases, respectively. A grade 4 hematological adverse event (AE) was observed in 1 patient. Grade 3–4 infection, including febrile neutropenia, was observed in 4 patients (10.5%). Although 2 patients dropped out due to AE, 94.7% of the patients completed the induction phase. However, because of a poor response to induction chemotherapy (<PR in 6 patients), poor stem cell mobilization (4 patients), and a protocol violation (1 patient), only 24 patients (63.2%) proceeded to ASCT. The 2-year progression-free and overall survivals were 55.3 and 82.7%, respectively. We thus believe that the therapeutic power of weekly CBD is not strong enough as a 3-drug induction regimen despite its feasibility for most Japanese patients.

Journal

Acta Haematologica – Karger

Published: Feb 1, 2019

Keywords: Multiple myeloma; Autologous stem cell transplantation; Induction; Cyclophosphamide; Bortezomib; Dexamethasone; Weekly cyclophosphamide-bortezomib-dexamethasone

References

  • Cancer incidence and incidence rates in Japan in 2009: a study of 32 population-based cancer registries for the Monitoring of Cancer Incidence in Japan (MCIJ) project
    Hori, M; Matsuda, T; Shibata, A; Katanoda, K; Sobue, T; Nishimoto, H
  • Impact on survival of high-dose therapy with autologous stem cell support in patients younger than 60 years with newly diagnosed multiple myeloma: a population-based study
    Lenhoff, S; Hjorth, M; Holmberg, E; Turesson, I; Westin, J; Nielsen, JL
  • High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma
    Child, JA; Morgan, GJ; Davies, FE; Owen, RG; Bell, SE; Hawkins, K
  • Bortezomib plus dexamethasone is superior to vincristine plus doxorubicin plus dexamethasone as induction treatment prior to autologous stem-cell transplantation in newly diagnosed multiple myeloma: results of the IFM 2005-01 phase III trial
    Harousseau, JL; Attal, M; Avet-Loiseau, H; Marit, G; Caillot, D; Mohty, M
  • Bortezomib induction and maintenance treatment in patients with newly diagnosed multiple myeloma: results of the randomized phase III HOVON-65/ GMMG-HD4 trial
    Sonneveld, P; Schmidt-Wolf, IG; van der Holt, B; El Jarari, L; Bertsch, U; Salwender, H
  • Cyclophosphamide, bortezomib and dexamethasone induction for newly diagnosed multiple myeloma: high response rates in a phase II clinical trial
    Reeder, CB; Reece, DE; Kukreti, V; Chen, C; Trudel, S; Hentz, J
  • Randomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myeloma
    Kumar, S; Flinn, I; Richardson, PG; Hari, P; Callander, N; Noga, SJ
  • Efficacy and safety of bortezomib-containing induction chemotherapy for autologous stem cell transplantationeligible Japanese multiple myeloma patients –A phase 2 multicenter trial
    Kudo, D; Ohashi, K; Komeno, K; Nakamura, Y; Shinagawa, A; Yoshida, C
  • Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group
  • Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation
    Bladé, J; Samson, D; Reece, D; Apperley, J; Björkstrand, B; Gahrton, G
  • International uniform response criteria for multiple myeloma
    Durie, BG; Harousseau, JL; Miguel, JS; Bladé, J; Barlogie, B; Anderson, K
  • Once- versus twice-weekly bortezomib induction therapy with CyBorD in newly diagnosed multiple myeloma
    Reeder, CB; Reece, DE; Kukreti, V; Chen, C; Trudel, S; Laumann, K
  • Phase II study of bortezomib, cyclophosphamide and dexamethasone as induction therapy in multiple myeloma: DSMM XI trial
    Einsele, H; Engelhardt, M; Tapprich, C; Müller, J; Liebisch, P; Langer, C
  • Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma
    Mai, EK; Bertsch, U; Dürig, J; Kunz, C; Haenel, M; Blau, IW
  • VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial
    Moreau, P; Hulin, C; Macro, M; Caillot, D; Chaleteix, C; Roussel, M
  • Subcutaneous bortezomib combined with weekly cyclophosphamide and dexamethasone is an efficient and well tolerated regime in newly diagnosed multiple myeloma
    Ong, SY; Ng, HY; Surendran, S; Linn, YC; Chen, Y; Goh, YT
  • Bortezomib-cyclophosphamide-dexamethasone (VCD) versus bortezomib-thalidomide-dexamethasone (VTD) -based regimens as induction therapies in newly diagnosed transplant eligible patients with multiple myeloma: a meta-analysis
    Leiba, M; Kedmi, M; Duek, A; Freidman, T; Weiss, M; Leiba, R