Please use this identifier to cite or link to this item: https://doi.org/10.1182/blood-2013-12-546374
Title: Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma
Authors: San-Miguel, J
Bladé, J
Shpilberg, O
Grosicki, S
Maloisel, F
Min, C.-K
Zarzuela, M.P
Robak, T
Prasad, S.V.S.S
Goh, Y.T 
Laubach, J
Spencer, A
Mateos, M.-V
Palumbo, A
Puchalski, T
Reddy, M
Uhlar, C
Qin, X
Van De Velde, H
Xie, H
Orlowski, R.Z
Keywords: antivirus agent
bisphosphonic acid derivative
bortezomib
immunoglobulin A
interleukin 6
melphalan
prednisone
siltuximab
add on therapy
adult
aged
anemia
article
bleeding
bone disease
bronchopneumonia
chromosome 17p
drug efficacy
drug fatality
drug response
drug safety
gastrointestinal disease
herpes zoster
human
hypokalemia
incidence
infection
leukocytoclastic vasculitis
maintenance therapy
major clinical study
multicenter study
multiple myeloma
neuralgia
neutropenia
overall survival
peripheral neuropathy
phase 2 clinical trial
pneumonia
priority journal
progression free survival
radius fracture
respiratory failure
sensory neuropathy
septic shock
suicide
thrombocytopenia
very elderly
Aged
Aged, 80 and over
Antibodies, Monoclonal
Antineoplastic Combined Chemotherapy Protocols
Boronic Acids
Chromosome Deletion
Chromosomes, Human, Pair 17
Disease-Free Survival
Female
Follow-Up Studies
Humans
Immunoglobulin A
Interleukin-6
Male
Melphalan
Middle Aged
Multiple Myeloma
Prednisone
Pyrazines
Survival Rate
Issue Date: 2014
Publisher: American Society of Hematology
Citation: San-Miguel, J, Bladé, J, Shpilberg, O, Grosicki, S, Maloisel, F, Min, C.-K, Zarzuela, M.P, Robak, T, Prasad, S.V.S.S, Goh, Y.T, Laubach, J, Spencer, A, Mateos, M.-V, Palumbo, A, Puchalski, T, Reddy, M, Uhlar, C, Qin, X, Van De Velde, H, Xie, H, Orlowski, R.Z (2014). Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma. Blood 123 (26) : 4136-4142. ScholarBank@NUS Repository. https://doi.org/10.1182/blood-2013-12-546374
Rights: Attribution 4.0 International
Abstract: Because interleukin-6 (IL-6) is considered important in the proliferation of early multiple myeloma (MM), we hypothesized that the addition of the anti-IL-6 monoclonal antibody siltuximab to the bortezomib-melphalan-prednisone (VMP) regimen would improve outcomes in transplant-ineligible patients with newly diagnosed MM. One hundred and six patients were randomized to receive 9 cycles of VMP or VMP plus siltuximab (11 mg/kg every 3 weeks) followed by siltuximab maintenance. Baseline characteristics were well balanced except for immunoglobulin A subtype and 17p deletions. With a complete response (CR) rate of 27% on siltuximab plus VMP (S+VMP) and 22% on VMP, the study did not confirm its hypothesis that the addition of siltuximab would increase the CR rate by at least 10%. Overall response rate was 88% on S+VMP and 80% on VMP, and at least very good partial response rates were 71% and 51% (P 5 .0382), respectively. Median progression-free survival (17 months) and 1-year overall survival (88%) were identical in the 2 arms. Grade ?3 adverse-event incidence was 92% on S1VMP and 81% on VMP ( P = .09), with trends toward more hematologic events and infections on S+VMP. Maintenance therapy with siltuximabwaswell tolerated. In conclusion, the addition of siltuximab toVMPdid not improve theCRrate or long-term outcomes. This study was registered at http://clinicaltrials.gov as #NCT00911859. © 2014 by The American Society of Hematology.
Source Title: Blood
URI: https://scholarbank.nus.edu.sg/handle/10635/183894
ISSN: 0006-4971
DOI: 10.1182/blood-2013-12-546374
Rights: Attribution 4.0 International
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