Abstract | BACKGROUND: METHODS/DESIGN: A multicenter, randomized, placebo-controlled, double-blind phase IIb trial will be conducted. Ninety patients with multiple myeloma scheduled for treatment with HDM and autologous HSCT will be included. Patients will be randomized between intravenous treatment with anakinra (300 mg) or placebo. Each group will be treated from day - 2 (day of HDM; day 0 is HSCT) up until day + 12. Outcome measures will be assessed at baseline, during admission, at discharge or day + 30, at day + 90, and + 1 year. The primary outcome will be reduction of FN. Secondary outcome measures include mucositis scores, bloodstream infections, citrulline levels, quality of life, and fatigue severity. DISCUSSION: The AFFECT-2 trial will examine the efficacy of anakinra in the management of fever during neutropenia and mucositis in patients with multiple myeloma treated with HDM and autologous HSCT. The results of this study may provide a new treatment option for these important complications. Also, this study will give us more insight in the pathophysiology of mucositis, including the role of IL-1 and the role of the microbiota in mucositis. TRIAL REGISTRATION: Clinicaltrials.gov NCT04099901 . Registered on September 23, 2019. EudraCT: 2018-005046-10.
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Authors | Charlotte E M de Mooij, Lenneke F J van Groningen, Anton F J de Haan, Bart J Biemond, Martijn Bakker, Walter J F M van der Velden, Nicole M A Blijlevens |
Journal | Trials
(Trials)
Vol. 21
Issue 1
Pg. 948
(Nov 23 2020)
ISSN: 1745-6215 [Electronic] England |
PMID | 33225965
(Publication Type: Clinical Trial Protocol, Journal Article)
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Chemical References |
- Interleukin 1 Receptor Antagonist Protein
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Topics |
- Double-Blind Method
- Hematopoietic Stem Cell Transplantation
(adverse effects)
- Humans
- Interleukin 1 Receptor Antagonist Protein
(adverse effects)
- Mucositis
(chemically induced, diagnosis)
- Multicenter Studies as Topic
- Neutropenia
(chemically induced, diagnosis)
- Pilot Projects
- Quality of Life
- Randomized Controlled Trials as Topic
- Transplantation, Autologous
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