Evidence map›Paper›PMID 38015467›Full record

ArticleEuropean journal of neurology2024

Lenalidomide in the treatment of anti-myelin-associated glycoprotein neuropathy: A phase 1 study to identify the maximum tolerated dose.

Amro M Stino, Naresh Bumma, Rachel Smith, Long Davalos, Jeff Allen, Jing Christine Ye, Matthew Pianko, Erica Campagnaro, Cassandra Fierro, Abdelrahman Awad and 6 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in European journal of neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03701711 (A Phase I Study of Lenalidomide in Combination with Dexamethasone in Anti-MAG Demyelinating Sensorimotor Neuropathy), 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
2.0field-weighted citation impact, top 12% 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.

NCT03701711 phase1terminatednot on this map

A Phase I Study of Lenalidomide in Combination with Dexamethasone in Anti-MAG Demyelinating Sensorimotor Neuropathy

TypeinterventionalSponsorOhio State UniversityRan2018 to 2022Enrolled11ConditionsDemyelinating Sensorimotor NeuropathyArmsLenalidomide
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
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

16 authors at 6 institutions in 1 country.

Amro M StinoDepartment of Neurology, Division of Neuromuscular Medicine, The University of Michigan Health System, Ann Arbor, Michigan, USA.ORCID 0000-0002-7793-6662
Naresh BummaDepartment of Internal Medicine, Division of Hematology-Oncology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Rachel SmithCenter for Biostatistics, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Long DavalosDepartment of Neurology, Division of Neuromuscular Medicine, The University of Cincinnati Medical Center, Cincinnati, Ohio, USA.
Jeff AllenDepartment of Neurology, Division of Neuromuscular Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Jing Christine YeDepartment of Internal Medicine, Division of Hematology-Oncology, The University of Michigan Health System, Ann Arbor, Michigan, USA.
Matthew PiankoDepartment of Internal Medicine, Division of Hematology-Oncology, The University of Michigan Health System, Ann Arbor, Michigan, USA.
Erica CampagnaroDepartment of Internal Medicine, Division of Hematology-Oncology, The University of Michigan Health System, Ann Arbor, Michigan, USA.
Cassandra FierroDepartment of Neurology, Division of Neuromuscular Medicine, The University of Michigan Health System, Ann Arbor, Michigan, USA.
Abdelrahman AwadDepartment of Neurology, Division of Neuromuscular Medicine, The University of Michigan Health System, Ann Arbor, Michigan, USA.
Ben MurdockDepartment of Neurology, Division of Neuromuscular Medicine, The University of Michigan Health System, Ann Arbor, Michigan, USA.
Maciej PietrzakDepartment of Biomedical Informatics, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Gerard LoszanskiDepartment of Pathology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
David M KlineDepartment of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Yvonne EfeberaDepartment of Oncology, Ohio Health, Columbus, Ohio, USA.
Bakri ElsheikhDepartment of Neurology, Division of Neuromuscular Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
University of Michigan · USThe Ohio State University Wexner Medical Center · USOhioHealth · USUniversity of Cincinnati · USUniversity of Minnesota · USWake Forest University · US

Funding

Bristol-Myers SquibbGBS/CIDP Foundation International
6 · The paper itself

Abstract

backgroundAnti-myelin-associated glycoprotein (MAG) neuropathy is a debilitating demyelinating polyneuropathy with no approved therapies. Our primary objective was to ascertain lenalidomide safety and maximum tolerated dose (MTD) in anti-MAG neuropathy.

methodsThis phase 1b, open-label, single-arm, dose-finding trial was conducted from 2019 through 2022. The original design included a dose-escalation/extension phase followed by a dose-expansion phase. Three doses of lenalidomide were evaluated: 10, 15, and 25 mg. The main outcome was the MTD.

resultsEleven patients enrolled (10 men), with a mean age of 67.6 years (SD = 6.18, range 58-77 years) and mean disease duration of 8.5 years (SD = 10.9, range 1-40 years). The study terminated early due to higher-than-expected non-dose-limiting toxicity venous thromboembolism (VTE) events. The calculated MTD was 25 mg (posterior mean of toxicity probability was 0.01 with a 95% credible interval of 0.00, 0.06), but a recommended phase 2 dose of 15 mg was advised. For secondary exploratory outcomes, only EQ-5D (-0.95, 95% CI -1.81 to -0.09) and total IgM (-162 mg/dL, 95% CI -298 to -26) showed signs of improvement by month 12.

conclusionsLenalidomide was associated with higher-than-expected VTE events in anti-MAG neuropathy patients, despite a calculated MTD of 25 mg. A recommended phase 2 dose of 15 mg was advised. Lenalidomide did not improve disability or impairment at 12 months, although this study was not powered for efficacy. The risks of long term lenalidomide may outweigh benefit for patients with anti-MAG neuropathy. Any future efficacy study should address VTE risk, as current myeloma guidelines appear inadequate.

trial registrationLenalidomide in Anti-MAG Neuropathy: Phase 1b Study, ClinicalTrials.gov Identifier: NCT03701711, https://clinicaltrials.gov/ct2/show/NCT03701711. First submitted October 10, 2018. First patient enrolled in January 2019.

Indexed as

Peripheral Nervous System DiseasesVenous ThromboembolismAgedAntineoplastic Combined Chemotherapy ProtocolsGlycoproteinsHumansLenalidomideMaleMaximum Tolerated DoseMiddle AgedGlycoproteinsLenalidomideanti-MAG neuropathydrug safetydrug triallenalidomideoutcome measures

Identifiers

PMID38015467
PMCPMC11235859
OpenAlexW4389078073

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.