A Study of a Human Anti-Intercellular Adhesion Molecule-1 Monoclonal Antibody, in Patients With Multiple Myeloma
A Phase I Dose-Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of BI 505, a Human Anti-Intercellular Adhesion Molecule 1 Monoclonal Antibody, in Patients With Relapsed/Refractory Multiple Myeloma
1 other identifier
interventional
35
4 countries
7
Brief Summary
This is a first in human study which will assess the safety and tolerability of a monoclonal antibody against ICAM-1 in patients with Multiple Myeloma. The tumour response rate will also be measured.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 multiple-myeloma
Started Dec 2009
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMarch 15, 2013
October 1, 2012
3.2 years
December 1, 2009
March 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests
four weeks
Study Arms (1)
BI-505
EXPERIMENTALInterventions
Anti-ICAM-1 monoclonal antibody given as a i.v infusion every second week for four weeks,
Eligibility Criteria
You may qualify if:
- Advanced Myeloma with measurable disease after at least 2 previous regimens.
- Life expectancy \> 3 months.
- Performance status ECOG \< 2.
You may not qualify if:
- No high dose steroids within 7 days prior to screening.
- Severe other conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
University of Utah Health Sciences Center, Department of Medicine, Division of Hematology, Utah Blood and Marrow Transplant and Myeloma Program
Salt Lake City, Utah, 84132-2408, United States
AZ Sint-Jan
Bruges, 8000, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Rigshospitalet
Copenhagen, 2100, Denmark
Karolinska University Hospital
Huddinge, 141 86, Sweden
Hematology Clinic Cancer Division, Skåne University Hospital
Lund, SE-22185, Sweden
Related Publications (1)
Hansson M, Gimsing P, Badros A, Niskanen TM, Nahi H, Offner F, Salomo M, Sonesson E, Mau-Sorensen M, Stenberg Y, Sundberg A, Teige I, Van Droogenbroeck J, Wichert S, Zangari M, Frendeus B, Korsgren M, Poelman M, Tricot G. A Phase I Dose-Escalation Study of Antibody BI-505 in Relapsed/Refractory Multiple Myeloma. Clin Cancer Res. 2015 Jun 15;21(12):2730-6. doi: 10.1158/1078-0432.CCR-14-3090. Epub 2015 Feb 24.
PMID: 25712687DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guido Tricot, MD, PhD, Prof.
University of Utah
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2009
First Posted
December 3, 2009
Study Start
December 1, 2009
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
March 15, 2013
Record last verified: 2012-10