Evidence map›Paper›PMID 32009091›Full record

Trial reportInternal medicine (Tokyo, Japan)2020

Lenalidomide Treatment for Thalidomide-refractory POEMS Syndrome: A Prospective Single-arm Clinical Trial.

Tomoki Suichi, Sonoko Misawa, Kengo Nagashima, Yasunori Sato, Yuta Iwai, Kanako Katayama, Yukari Sekiguchi, Kazumoto Shibuya, Hiroshi Amino, Yo-Ichi Suzuki and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Internal medicine (Tokyo, Japan), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02193698 (Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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.

NCT02193698 phase2completednot on this map

Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase (POEMS) Syndrome

TypeinterventionalSponsorChiba UniversityRan2014 to 2016Enrolled5ConditionsPOEMS SyndromeArmsLenalidomide+Dexamethasone
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Review
  3. POEMS syndrome: diagnosis, treatments, and outcomes.Hematology. American Society of Hematology. Education Program · 2025
    Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Paraproteinemia and neuropathy.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021
    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

13 authors.

Tomoki SuichiDepartment of Neurology, Graduate School of Medicine, Chiba University, Japan.
Sonoko MisawaDepartment of Neurology, Graduate School of Medicine, Chiba University, Japan.
Kengo NagashimaResearch Center for Medical and Health Data Science, The Institute of Statistical Mathematics, Japan.
Yasunori SatoDepartment of Preventive Medicine and Public Health, School of Medicine, Keio University, Japan.
Yuta IwaiDepartment of Neurology, Graduate School of Medicine, Chiba University, Japan.
Kanako KatayamaClinical Research Center, Chiba University Hospital, Japan.
Yukari SekiguchiDepartment of Neurology, Graduate School of Medicine, Chiba University, Japan.
Kazumoto ShibuyaDepartment of Neurology, Graduate School of Medicine, Chiba University, Japan.
Hiroshi AminoDepartment of Neurology, Graduate School of Medicine, Chiba University, Japan.
Yo-Ichi SuzukiDepartment of Neurology, Graduate School of Medicine, Chiba University, Japan.
Atsuko TsuneyamaDepartment of Neurology, Graduate School of Medicine, Chiba University, Japan.
Keigo NakamuraDepartment of Neurology, Graduate School of Medicine, Chiba University, Japan.
Satoshi KuwabaraDepartment of Neurology, Graduate School of Medicine, Chiba University, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective A randomized controlled trial has shown the efficacy of thalidomide against polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; however, there are still refractory patients. We studied the effects of lenalidomide, a derivative of thalidomide, on patients refractory to thalidomide. Methods This prospective single-arm trial evaluated the safety and efficacy of lenalidomide plus dexamethasone in refractory or recurrent patients with POEMS syndrome. The regimen was administered as six 28-day cycles with lenalidomide on days 1-21 (15 mg in cycle 1, and 25 mg in cycle 2-6) plus dexamethasone once a week (20 mg). The primary endpoints were the rate of reduction in the serum vascular endothelial growth factor (VEGF) level at 24 weeks and the incidence of adverse events. This trial was registered with ClinicalTrial.gov, NCT02193698. Results Between July 2014 and December 2015, five men were enrolled. All patients had been refractory to thalidomide plus dexamethasone for more than 24 weeks. The mean rate of reduction in the serum VEGF level at 24 weeks was 59.6%±8.3% (p=0.0003). The mean serum VEGF level decreased from 2,466±771 pg/mL to 974±340 pg/mL. No serious adverse events were observed, and all patients completed six cycles treatment. Discussion Lenalidomide is a therapeutic option for thalidomide-refractory patients with POEMS syndrome.

Indexed as

DexamethasoneDrug Therapy, CombinationFemaleHumansImmunologic FactorsLenalidomideMaleMiddle AgedPOEMS SyndromeProspective StudiesThalidomideTreatment OutcomeVascular Endothelial Growth Factor AYoung AdultDexamethasoneImmunologic FactorsLenalidomideThalidomideVascular Endothelial Growth Factor Aclinical triallenalidomidePOEMS syndromethalidomideVEGF

Identifiers

PMID32009091
PMCPMC7270764

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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.