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Randomized, double-blind, placebo-controlled, multicenter study of siltuximab in high-risk smoldering multiple myeloma

Purpose: Interleukin-6 is important for the growth and survival of myeloma cells. This study evaluated blocking IL-6 with siltuximab to delay the transition from high-risk smoldering (SMM) to multiple myeloma (MM). Experimental Design: In a randomized, double-blind, placebo-controlled, multicenter s...

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Main Authors: Brighton, Timothy (Author) , Khot, Amit (Author) , Harrison, Simon J. (Author) , Ghez, David (Author) , Weiss, Brendan M. (Author) , Kirsch, Andreas (Author) , Magen, Hila (Author) , Gironella, Mercedes (Author) , Oriol, Albert (Author) , Streetly, Matthew (Author) , Kranenburg, Britte (Author) , Qin, Xiang (Author) , Bandekhar, Rajesh (Author) , Hu, Peter (Author) , Guilfoyle, Mary (Author) , Qi, Ming (Author) , Nemat, Sepideh (Author) , Goldschmidt, Hartmut (Author)
Format: Article (Journal)
Language:English
Published: March 19, 2019
In: Clinical cancer research
Year: 2019, Volume: 25, Issue: 13, Pages: 3772-3775
ISSN:1557-3265
DOI:10.1158/1078-0432.CCR-18-3470
Online Access:Verlag, Pay-per-use, Volltext: http://dx.doi.org/10.1158/1078-0432.CCR-18-3470
Verlag, Pay-per-use, Volltext: https://clincancerres.aacrjournals.org/content/early/2019/03/19/1078-0432.CCR-18-3470
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Author Notes:Timothy A. Brighton, Amit Khot, Simon J. Harrison, David Ghez, Brendan M. Weiss, Andreas Kirsch, Hila Magen, Mercedes Gironella, Albert Oriol, Matthew Streetly, Britte Kranenburg, Xiang Qin, Rajesh Bandekhar, Peter Hu, Mary Guilfoyle, Ming Qi, Sepideh Nemat, Hartmut Goldschmidt
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Summary:Purpose: Interleukin-6 is important for the growth and survival of myeloma cells. This study evaluated blocking IL-6 with siltuximab to delay the transition from high-risk smoldering (SMM) to multiple myeloma (MM). Experimental Design: In a randomized, double-blind, placebo-controlled, multicenter study, 85 patients with high-risk SMM were randomized to 15 mg/kg siltuximab (43 patients) or placebo (42 patients). The primary endpoint was 1-year PFS rate, based on IMWG CRAB criteria. Secondary endpoints included progressive disease indicator rate, PFS and safety. Results: Median age was 62 years (range: 21-84); 57% were male and 87% had a baseline ECOG score of 0. The 1-year PFS rate was 84.5% (siltuximab) and 74.4% (placebo). After a median follow-up of 29.2 months, 32.6% of PFS events occurred with siltuximab and 42.9% with placebo. Median PFS was not reached with siltuximab but was 23.5 months with placebo [HR 0.50 (95% CI: 0.24,1.04), p=0.0597]. The safety profile of siltuximab was comparable to placebo. Most AEs in the siltuximab group were Grade 2/3, most common SAEs were infections/infestations, and renal/urinary disorders. Mortality (3-siltuximab, 4-placebo) was low in both groups. Conclusions: Although this study did not meet the prespecified protocol hypothesis criteria, data suggest that siltuximab may delay the progression of high-risk SMM.
Item Description:Gesehen am 30.08.2019
Physical Description:Online Resource
ISSN:1557-3265
DOI:10.1158/1078-0432.CCR-18-3470

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