Evidence map›Paper›PMID 28158311›Full record

Trial reportPloS one2017

A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with BI-505, a human anti-intercellular adhesion molecule-1 monoclonal antibody, in patients with smoldering multiple myeloma.

Stina Wichert, Gunnar Juliusson, Åsa Johansson, Elisabeth Sonesson, Ingrid Teige, Anna Teige Wickenberg, Björn Frendeus, Magnus Korsgren, Markus Hansson

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01838369 (A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti-Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Smoldering Multiple Myeloma), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
4.3field-weighted citation impact, top 5% 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.

NCT01838369 phase2terminatednot on this map

A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti-Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Smoldering Multiple Myeloma

TypeinterventionalSponsorBioInvent International ABRan2013 to 2014Enrolled4ConditionsSmoldering Multiple MyelomaArmsBI-505
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
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  14. Facts and Hopes in Multiple Myeloma Immunotherapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Review
  15. Article
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  17. Review
  18. Review
  19. Potent Activity of an Anti-ICAM1 Antibody-Drug Conjugate against Multiple Myeloma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Article
  20. 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

9 authors at 3 institutions in 1 country.

Stina WichertDepartment of Hematology, Skåne University Hospital and Lund University, Lund, Sweden.
Gunnar JuliussonDepartment of Hematology, Skåne University Hospital and Lund University, Lund, Sweden.
Åsa JohanssonClinical Immunology and Transfusion Medicine, University and Regional Laboratories Region Skåne, Lund, Sweden.
Elisabeth SonessonClinical Development, BioInvent International AB, Lund, Sweden.
Ingrid TeigeResearch, BioInvent International AB, Lund, Sweden.
Anna Teige WickenbergClinical Development, BioInvent International AB, Lund, Sweden.
Björn FrendeusResearch, BioInvent International AB, Lund, Sweden.
Magnus KorsgrenClinical Development, BioInvent International AB, Lund, Sweden.
Markus HanssonDepartment of Hematology, Skåne University Hospital and Lund University, Lund, Sweden.
BioInvent (Sweden) · SELund University · SESkåne University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSmoldering multiple myeloma (SMM) is an indolent disease stage, considered to represent the transition phase from the premalignant MGUS (Monoclonal Gammopathy of Undetermined Significance) state towards symptomatic multiple myeloma (MM). Even though this diagnosis provides an opportunity for early intervention, few treatment studies have been done and the current standard of care is observation until progression. BI-505, a monoclonal antibody directed against intercellular adhesion molecule 1 (ICAM-1) with promising anti-myeloma activity in preclinical trials, is a possible treatment approach for this patient category with potential to eliminate tumor cells with minimal long-term side effects. BI-505 was well tolerated in an earlier phase 1 trial. METHODS AND

findingsIn this phase 2 trial the effects of BI-505 in patients with SMM were studied. Four patients were enrolled and three of them completed the first cycle of treatment defined as 5 doses of BI-505, a total of 43 mg/kg BW, over a 7-week period. In the three evaluable patients, BI-505 showed a benign safety profile. None of the patients achieved a response as defined per protocol. EudraCT number: 2012-004884-29.

conclusionsThe study was conducted to assess the efficacy, safety and pharmacodynamics of BI-505 in patients with SMM. BI-505 showed no clinically relevant efficacy on disease activity in these patients with SMM, even if well tolerated.

trial registrationClinicalTrials.gov Identifier: NCT01838369.

Indexed as

AgedAntibodies, MonoclonalAntineoplastic AgentsBiomarkersFemaleHumansIntercellular Adhesion Molecule-1Leukocyte CountMaleMiddle AgedMonoclonal Gammopathy of Undetermined SignificanceTreatment OutcomeAntibodies, MonoclonalAntineoplastic AgentsBiomarkersIntercellular Adhesion Molecule-1

Identifiers

PMID28158311
PMCPMC5291423
OpenAlexW2585373193

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.