Title: Fewer bone disease events, improvement in bone remodeling, and evidence of bone healing with bortezomib plus melphalan-prednisone vs. melphalan-prednisone in the phase III VISTA trial in multiple myeloma
Authors: Delforge, Michel ×
Terpos, Evangelos
Richardson, Paul G
Shpilberg, Ofer
Khuageva, Nuriet K
Schlag, Rudolf
Dimopoulos, Meletios A
Kropff, Martin
Spicka, Ivan
Petrucci, Maria Teresa
Samoilova, Olga S
Mateos, Maria-Victoria
Magen-Nativ, Hila
Goldschmidt, Hartmut
Esseltine, Dixie-Lee
Ricci, Deborah S
Liu, Kevin
Deraedt, William
Cakana, Andrew
van de Velde, Helgi
San Miguel, Jesús F #
Issue Date: Mar-2011
Publisher: Munksgaard
Series Title: European Journal of Haematology vol:86 issue:5 pages:372-384
Article number: 10.1111/j.1600-0609.2011.01599.x
Abstract: Objectives:  Bone disease is a key presenting feature of myeloma. This post-hoc analysis of the phase III VISTA trial of bortezomib plus melphalan-prednisone (VMP) versus MP in previously untreated myeloma patients assessed clinical bone disease events and changes in alkaline phosphatase (ALP), a marker for osteoblast activation, and serum Dickkopf-1 (DKK-1), an inhibitor of osteoblast differentiation, during treatment. Methods:  Patients received nine 6-week cycles of VMP (bortezomib 1.3 mg/m(2) , days 1, 4, 8, 11, 22, 25, 29, 32, cycles 1-4, days 1, 8, 22, 29, cycles 5-9, plus melphalan 9 mg/m(2) and prednisone 60 mg/m(2) , days 1-4, cycles 1-9; N=344) or MP alone (N=338). Results:  Rates of bisphosphonates use during treatment (73% vs. 82%), progression due to worsening bone disease (3% vs. 11%), and requirement for subsequent radiotherapy (3% vs. 8%) were lower with VMP vs. MP. Median maximum ALP increase was significantly higher with VMP vs. MP overall (49.7% vs. 30.3%, P=0.029), and higher by response group (complete response [CR]: 68.7% vs. 43.9%; partial response [PR]: 41.5% vs. 31.2%). Greater maximum ALP increase was strongly associated with achievement of CR (P≤0.0001) and CR/PR (P≤0.01). Median DKK-1 decreased with VMP by 694.4pg/mL and increased with MP by 1273.3pg/mL from baseline to day 4 (P=0.0069). Available radiologic data revealed evidence of bone healing in 6/11 VMP-treated patients, who achieved best responses of 3 CR, 1 PR, and 2 stable disease. Conclusions:  These results suggest a positive effect of bortezomib on bone metabolism and potentially bone healing in myeloma. ( identifier: NCT00111319).
ISSN: 0902-4441
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Hematology Section (-)
× corresponding author
# (joint) last author

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