Back to resultsA Study of a Human Anti-Intercellular Adhesion Molecule-1 Monoclonal Antibody, in Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BI-505
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, monoclonal antibody, safety, pharmacokinetic
Eligibility Criteria
Inclusion Criteria:
- Advanced Myeloma with measurable disease after at least 2 previous regimens.
- Life expectancy > 3 months.
- Performance status ECOG < 2.
Exclusion Criteria:
- Prior antineoplastic therapy within 4 weeks prior to inclusion.
- No high dose steroids within 7 days prior to screening.
- Severe other conditions.
Sites / Locations
- University of Maryland, Greenebaum Cancer Center
- University of Utah Health Sciences Center, Department of Medicine, Division of Hematology, Utah Blood and Marrow Transplant and Myeloma Program
- AZ Sint-Jan
- Ghent University Hospital
- Rigshospitalet
- Karolinska University Hospital
- Hematology Clinic Cancer Division, Skåne University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BI-505
Arm Description
Outcomes
Primary Outcome Measures
Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests
Secondary Outcome Measures
Full Information
NCT ID
NCT01025206
First Posted
December 1, 2009
Last Updated
March 14, 2013
Sponsor
BioInvent International AB
1. Study Identification
Unique Protocol Identification Number
NCT01025206
Brief Title
A Study of a Human Anti-Intercellular Adhesion Molecule-1 Monoclonal Antibody, in Patients With Multiple Myeloma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioInvent International AB
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, monoclonal antibody, safety, pharmacokinetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BI-505
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
BI-505
Intervention Description
Anti-ICAM-1 monoclonal antibody given as a i.v infusion every second week for four weeks,
Primary Outcome Measure Information:
Title
Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests
Time Frame
four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced Myeloma with measurable disease after at least 2 previous regimens.
Life expectancy > 3 months.
Performance status ECOG < 2.
Exclusion Criteria:
Prior antineoplastic therapy within 4 weeks prior to inclusion.
No high dose steroids within 7 days prior to screening.
Severe other conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Tricot, MD, PhD, Prof.
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Utah Health Sciences Center, Department of Medicine, Division of Hematology, Utah Blood and Marrow Transplant and Myeloma Program
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-2408
Country
United States
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Karolinska University Hospital
City
Huddinge
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Hematology Clinic Cancer Division, Skåne University Hospital
City
Lund
ZIP/Postal Code
SE-22185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
25712687
Citation
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.
Results Reference
derived
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A Study of a Human Anti-Intercellular Adhesion Molecule-1 Monoclonal Antibody, in Patients With Multiple Myeloma
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