Evidence map›Paper›PMID 36802032›Full record

Trial reportJournal of neurology2023

Neurofilament light chain levels indicate acute axonal damage under bortezomib treatment.

Nadine Cebulla, Daniel Schirmer, Eva Runau, Leon Flamm, Sonja Gommersbach, Helena Stengel, Xiang Zhou, Hermann Einsele, Ann-Kristin Reinhold, Bruno Rogalla von Bieberstein and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Journal of neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07025005 (Clinical Study to Evaluate the Possible Role of Fenofibrate in the Prophylaxis From Peripheral Neuropathy Induced by Bortezomib, Lenalidomide and Dexamethasone Protocol in the Treatment of Patients With Multiple Myeloma), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
8.1field-weighted citation impact, top 2% 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.

NCT07025005 phase4recruitingnot on this mapstarted 2025, after this paper: background citation

Clinical Study to Evaluate the Possible Role of Fenofibrate in the Prophylaxis From Peripheral Neuropathy Induced by Bortezomib, Lenalidomide and Dexamethasone Protocol in the Treatment of Patients With Multiple Myeloma

TypeinterventionalSponsorTanta UniversityRan2025 to 2026Enrolled44ConditionsPeripheral Neuropathy, Multiple Myeloma, NeoplasmsArmsBortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet, Bortezomib + Lenalidomide + Dexamethasone
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

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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

14 authors at 1 institution in 1 country.

Nadine CebullaDepartment of Neurology, University Hospital Würzburg, Würzburg, Germany. Cebulla_N@ukw.de.ORCID http://orcid.org/0000-0002-2376-2281
Daniel SchirmerDepartment of Neurology, University Hospital Würzburg, Würzburg, Germany.
Eva RunauDepartment of Neurology, University Hospital Würzburg, Würzburg, Germany.
Leon FlammDepartment of Neurology, University Hospital Würzburg, Würzburg, Germany.
Sonja GommersbachDepartment of Neurology, University Hospital Würzburg, Würzburg, Germany.
Helena StengelDepartment of Neurology, University Hospital Würzburg, Würzburg, Germany.
Xiang ZhouDepartment of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany.
Hermann EinseleDepartment of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany.
Ann-Kristin ReinholdDepartment of Anesthesiology, University Hospital Würzburg, Würzburg, Germany.
Bruno Rogalla von BiebersteinDepartment of Anesthesiology, University Hospital Würzburg, Würzburg, Germany.
Daniel ZellerDepartment of Neurology, University Hospital Würzburg, Würzburg, Germany.
Heike RittnerDepartment of Anesthesiology, University Hospital Würzburg, Würzburg, Germany.
K Martin KortümDepartment of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany.
Claudia SommerDepartment of Neurology, University Hospital Würzburg, Würzburg, Germany.
Universitätsklinikum Würzburg · DE

Funding

Deutsche Forschungsgemeinschaft DFG KO 4604/2-1Deutsche Forschungsgemeinschaft DFG So 328/15-1
6 · The paper itself

Abstract

introductionBortezomib (BTZ) is a selective and reversible proteasome inhibitor and first line treatment for multiple myeloma (MM). One of the side effects is BTZ-induced peripheral neuropathy (BIPN). Until now there is no biomarker which can predict this side effect and its severity. Neurofilament light chain (NfL) is a neuron specific cytoskeletal protein, of which higher levels can be detected in peripheral blood in case of axon damage. In this study, we aimed to evaluate the relationship between NfL serum levels and characteristics of BIPN.

methodsWe performed a first interim analysis of a monocentric, non-randomized, observational clinical trial including 70 patients (DRKS00025422) diagnosed with MM in the inclusion period of June 2021 until March 2022. Two groups of patients-one with ongoing BTZ treatment at the time of recruiting, and one with BTZ treatment in the past-were compared to controls. NfL in serum was analyzed via the ELLA™ device.

resultsBoth patients with previous and ongoing BTZ treatment had higher serum NfL levels than controls, and patients with ongoing BTZ treatment had higher NfL levels than patients with BTZ treatment in the past. Serum NfL levels correlated with electrophysiological measures of axonal damage in the group with ongoing BTZ treatment.

conclusionElevated NfL levels indicate acute axonal damage under BTZ in MM patients.

Indexed as

Intermediate FilamentsMultiple MyelomaAxonsBortezomibHumansNeurofilament ProteinsProteasome InhibitorsBortezomibNeurofilament ProteinsProteasome InhibitorsBortezomibBortezomib-induced peripheral neuropathyMultiple myelomaNerve conduction studiesNeurofilament light chainPeripheral neuropathy

Identifiers

PMID36802032
PMCPMC10188420
OpenAlexW4321351585

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.