Anakinra: Safety and Efficacy in the Management of Fever During Neutropenia and Mucositis in ASCT
Status:
Completed
Trial end date:
2020-08-01
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 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.
In this phase IIa study the safety, maximum tolerated dose and efficacy of anakinra, a
recombinant human IL-1 receptor antagonist, will be determined in adult patients with
multiple myeloma who receive high-dose melphalan (HDM) in the preparation for an autologous
hematopoietic stem cell transplantation (ASCT) and are at high risk for experiencing
mucositis and fever during neutropenia (FN). After establishing the optimal dose, a pivotal
double-blind randomized placebo-controlled multicenter phase IIb trial will be planned to
establish efficacy.