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2014 ; 123
(26
): 4136-42
Nephropedia Template TP
gab.com Text
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English Wikipedia
Phase 2 randomized study of bortezomib-melphalan-prednisone with or without
siltuximab (anti-IL-6) in multiple myeloma
#MMPMID24833354
San-Miguel J
; Bladé J
; Shpilberg O
; Grosicki S
; Maloisel F
; Min CK
; Polo Zarzuela M
; Robak T
; Prasad SV
; Tee Goh Y
; Laubach J
; Spencer A
; Mateos MV
; Palumbo A
; Puchalski T
; Reddy M
; Uhlar C
; Qin X
; van de Velde H
; Xie H
; Orlowski RZ
Blood
2014[Jun]; 123
(26
): 4136-42
PMID24833354
show ga
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 = .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 S+VMP and
81% on VMP (P = .09), with trends toward more hematologic events and infections
on S+VMP. Maintenance therapy with siltuximab was well tolerated. In conclusion,
the addition of siltuximab to VMP did not improve the CR rate or long-term
outcomes. This study was registered at http://clinicaltrials.gov as #NCT00911859.
free
free
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