Evidence map›Paper›PMID 28261656›Full record

ArticleOncology and therapy2016

Phase I Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Patients with Previously Treated Multiple Myeloma.

Rachid C Baz, Jeffrey A Zonder, Cristina Gasparetto, Frederic J Reu, Vincent Strout

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Oncology and therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00775502 (Open-Label, Multi-Center, Dose Escalation Phase 1/2 Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Subjects With Previously Treated Multiple Myeloma), 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 30% 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.

NCT00775502 phase1terminatednot on this map

Open-Label, Multi-Center, Dose Escalation Phase 1/2 Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Subjects With Previously Treated Multiple Myeloma

TypeinterventionalSponsorKyowa Kirin Co., Ltd.Ran2008 to 2011Enrolled23ConditionsMultiple MyelomaArmsBIW-8962
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Complement System: a Neglected Pathway in Immunotherapy.Clinical reviews in allergy & immunology · 2020
    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

5 authors at 5 institutions in 1 country.

Rachid C BazDepartment of Malignant Hematology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL USA.
Jeffrey A ZonderDepartment of Oncology, Barbara Ann Karmanos Cancer Institute, Detroit, MI USA.
Cristina GasparettoDuke Adult Blood and Marrow Transplant Clinic, Duke University Medical Center, Durham, NC USA.
Frederic J ReuDepartment of Hematology and Oncology, Cleveland Clinic Foundation, Cleveland, OH USA.
Vincent StroutKyowa Kirin Pharmaceutical Development, Inc., Princeton, NJ USA.
Cleveland Clinic · USDuke Medical Center · USKirin (United States) · USMoffitt Cancer Center · USThe Barbara Ann Karmanos Cancer Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBIW-8962 is a monoclonal antibody to GM2 ganglioside that shows preclinical activity towards multiple myeloma (MM) cell lines and in animal models bearing MM xenografts. The objective of this study was to determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, potential immunogenicity, and preliminary clinical efficacy of BIW-8962 in patients with heavily pretreated MM.

methodsPatients (

resultsThe MTD of BIW-8962 was not established and BIW-8962 was relatively well tolerated. No pattern of consistent toxicity could be inferred from treatment-related AEs grade ≥3 and only two dose-limiting toxicities were recorded (atrial thrombosis + cardiomyopathy and chest pain, respectively). In the efficacy evaluable population (

conclusionBIW-8962 did not show evidence of clinical activity. The study was therefore stopped and further development of BIW-8962 in MM was halted.

fundingThis work was funded by Kyowa Kirin Pharmaceutical Development, Inc. TRIAL REGISTERED: ClinicalTrials.gov identifier, NCT00775502.

Indexed as

Anti-GM2 ganglioside monoclonal antibodyBIW-8962Multiple myelomaPhase I trialSafety

Identifiers

PMID28261656
PMCPMC5315068
OpenAlexW2548881614

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.