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A phase 2 multicentre study of siltuximab, an anti-interleukin-6 monoclonal antibody, in patients with relapsed or refractory multiple myeloma.

British journal of haematology (2013-02-26)
Peter M Voorhees, Robert F Manges, Pieter Sonneveld, Sundar Jagannath, George Somlo, Amrita Krishnan, Suzanne Lentzsch, Richard C Frank, Sonja Zweegman, Pierre W Wijermans, Robert Z Orlowski, Britte Kranenburg, Brett Hall, Tineke Casneuf, Xiang Qin, Helgi van de Velde, Hong Xie, Sheeba K Thomas
ABSTRACT

Interleukin-6 (IL6) plays a central role in multiple myeloma pathogenesis and confers resistance to corticosteroid-induced apoptosis. We therefore evaluated the efficacy and safety of siltuximab, an anti-IL6 monoclonal antibody, alone and in combination with dexamethasone, for patients with relapsed or refractory multiple myeloma who had ≥ 2 prior lines of therapy, one of which had to be bortezomib-based. Fourteen initial patients received siltuximab alone, 10 of whom had dexamethasone added for suboptimal response; 39 subsequent patients were treated with concurrent siltuximab and dexamethasone. Patients received a median of four prior lines of therapy, 83% were relapsed and refractory, and 70% refractory to their last dexamethasone-containing regimen. Suppression of serum C-reactive protein levels, a surrogate marker of IL6 inhibition, was demonstrated. There were no responses to siltuximab but combination therapy yielded a partial (17%) + minimal (6%) response rate of 23%, with responses seen in dexamethasone-refractory disease. The median time to progression, progression-free survival and overall survival for combination therapy was 4.4, 3.7 and 20.4 months respectively. Haematological toxicity was common but manageable. Infections occurred in 57% of combination-treated patients, including ≥ grade 3 infections in 18%. Further study of siltuximab in modern corticosteroid-containing myeloma regimens is warranted, with special attention to infection-related toxicity.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Graphene ink in water, inkjet printable
Sigma-Aldrich
Anti-IL6 antibody produced in rabbit, IgG fraction of antiserum, buffered aqueous solution
Sigma-Aldrich
Anti-IL6 high affinity antibody, Mouse monoclonal, clone IL6-2A3, purified from hybridoma cell culture
Sigma-Aldrich
Anti-IL6 high affinity antibody, Mouse monoclonal, clone IL6-4G1, purified from hybridoma cell culture
Sigma-Aldrich
SILuRich Anti-IL6 MAb, biotin conjugated, clone IL6-4G1, purified from hybridoma cell culture

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