Evidence map›Paper›PMID 33225965›Full record

ArticleTrials2020

Anakinra: efficacy in the management of fever during neutropenia and mucositis in autologous stem cell transplantation (AFFECT-2)-study protocol for a multicenter randomized double-blind placebo-controlled trial.

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04099901 (Anakinra), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04099901 phase2completednot on this map

Anakinra: Efficacy of Anakinra for the Management of Fever During Neutropenia and Mucositis in Patients With Multiple Myeloma Receiving an Autologous Hematopoietic Stem Cell Transplantation After High-dose Melphalan - An RCT

TypeinterventionalSponsorRadboud University Medical CenterRan2019 to 2024Enrolled88ConditionsMultiple MyelomaArmsAnakinra, Placebos
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. The Role of the Innate Immune Response in Oral Mucositis Pathogenesis.International journal of molecular sciences · 2023
    Review
  3. Mucositis and Infection in Hematology Patients.International journal of molecular sciences · 2023
    Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Charlotte E M de MooijRadboud Institute of Health Sciences, Department of Hematology, Radboud University Medical Center, PO Box 9101, 6500, HB, Nijmegen, the Netherlands. C.deMooij@Radboudumc.nl.ORCID http://orcid.org/0000-0003-3210-2215
Lenneke F J van GroningenRadboud Institute of Health Sciences, Department of Hematology, Radboud University Medical Center, PO Box 9101, 6500, HB, Nijmegen, the Netherlands.
Anton F J de HaanDepartment for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.
Bart J BiemondDepartment of Hematology, Amsterdam UMC, Amsterdam, the Netherlands.
Martijn BakkerDepartment of Hematology, University Medical Center Groningen, Groningen, the Netherlands.
Walter J F M van der VeldenRadboud Institute of Health Sciences, Department of Hematology, Radboud University Medical Center, PO Box 9101, 6500, HB, Nijmegen, the Netherlands.
Nicole M A BlijlevensRadboud Institute of Health Sciences, Department of Hematology, Radboud University Medical Center, PO Box 9101, 6500, HB, Nijmegen, the Netherlands.
Radboud University Nijmegen · NLAmsterdam University Medical Centers · NLUniversity Medical Center Groningen · NL

Funding

KWF Kankerbestrijding 11236
6 · The paper itself

Abstract

backgroundSince decades, fever and infections have been the most important complications of intensive chemotherapy and hematopoietic stem cell transplantation (HSCT) in the treatment of hematologic malignancies. Neutropenia has long been considered to be the most important risk factor for these complications. However, recent studies have shown that not neutropenia, but the development of mucositis is the most important cause of these complications. Currently, limited options for the prevention and treatment of mucositis are available, of which most are only supportive. The pro-inflammatory cytokine interleukin-1 (IL-1) plays a crucial role in the pathogenesis of mucositis. Pre-clinical studies of chemotherapy-induced mucositis have shown that recombinant human IL-1 receptor antagonist anakinra significantly ameliorated intestinal mucositis. In our pilot study AFFECT-1, we examined the safety and maximal tolerated dose of anakinra in patients with multiple myeloma, treated with high-dose melphalan (HDM) and autologous HSCT, selecting a dose of 300 mg daily for the phase IIb trial. The aim of the AFFECT-2 study is to determine the efficacy of anakinra in preventing fever during neutropenia (FN) and mucositis in this study population. METHODS/

designA 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 registrationClinicaltrials.gov NCT04099901 . Registered on September 23, 2019. EudraCT: 2018-005046-10.

Indexed as

Hematopoietic Stem Cell TransplantationMucositisNeutropeniaDouble-Blind MethodHumansInterleukin 1 Receptor Antagonist ProteinMulticenter Studies as TopicPilot ProjectsQuality of LifeRandomized Controlled Trials as TopicTransplantation, AutologousInterleukin 1 Receptor Antagonist ProteinAnakinraFebrile neutropeniaHematopoietic stem cell transplantationInterleukin-1MicrobiotaMucositisMultiple myelomaProtocolRandomized controlled trial

Identifiers

PMID33225965
PMCPMC7681989
OpenAlexW3109141774

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.