Anakinra: Efficacy in the Management of Fever During Neutropenia and Mucositis in ASCT - A Randomized Controlled Trial
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
Oral and intestinal mucositis are major risk factors for the occurrence of fever during
neutropenia and bloodstream infections after intensive chemo- and radiotherapy. These
complications often require dose reductions or cause delay of treatment, and thereby
interfere with optimal anticancer treatment. Currently, there are no effective strategies to
prevent or treat mucositis and the related complications.
The pro-inflammatory cytokine interleukin-1β (IL-1β) has shown to be pivotal in the
pathogenesis of mucositis and recently, it has been established in murine models that IL-1
inhibition significantly ameliorates chemotherapy-induced intestinal mucositis.
The investigators recently conducted a phase IIa study (AFFECT-1, NCT03233776) studying the
safety and maximum tolerated dose of anakinra, a recombinant human IL-1 receptor antagonist
in adult patients with multiple myeloma receiving high-dose melphalan (HDM) in the
preparation for an autologous hematopoietic stem cell transplantation (ASCT) who are at high
risk for experiencing mucositis and fever during neutropenia (FN).
Since treatment with anakinra has shown to be safe in this study population, the
investigators will continue with a double-blind randomized placebo-controlled multicenter
phase IIb trial to establish efficacy in the management of fever during neutropenia and
mucositis.