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

PLoS One

Elisabeth Sonesson¹  Anna Teige Wickenberg¹  Magnus Korsgren¹  Åsa Johansson²  Stina Wichert³  Markus Hansson³  Gunnar Juliusson³  Ingrid Teige⁴  Björn Frendeus⁴ 

[1] Clinical Development, BioInvent International AB, Lund, Sweden;Clinical Immunology and Transfusion Medicine, University and Regional Laboratories Region Skåne, Lund, Sweden;Department of Hematology, Skåne University Hospital and Lund University, Lund, Sweden;Research, BioInvent International AB, Lund, Sweden

关键词: Multiple myeloma;    Adverse events;    Serum proteins;    Cancer treatment;    Monoclonal antibodies;    Phase II clinical investigation;    Pharmacodynamics;    Phase I clinical investigation;   

DOI  :  10.1371/journal.pone.0171205

学科分类：医学（综合）

来源: Public Library of Science

【 摘 要 】

Background Smoldering 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 findings In 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. Conclusions The 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 registration ClinicalTrials.gov Identifier: NCT01838369.

【 授权许可】

CC BY