A Study of a Human Anti-Intercellular Adhesion Molecule-1 Monoclonal Antibody, in Patients With Multiple Myeloma
Phase 1
Completed
- Conditions
- Multiple Myeloma
- Interventions
- Biological: BI-505
- Registration Number
- NCT01025206
- Lead Sponsor
- BioInvent International AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Advanced Myeloma with measurable disease after at least 2 previous regimens.
- Life expectancy > 3 months.
- Performance status ECOG < 2.
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Exclusion Criteria
- Prior antineoplastic therapy within 4 weeks prior to inclusion.
- No high dose steroids within 7 days prior to screening.
- Severe other conditions.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BI-505 BI-505 -
- Primary Outcome Measures
Name Time Method Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests four weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Rigshospitalet
🇩🇰Copenhagen, Denmark
University of Utah Health Sciences Center, Department of Medicine, Division of Hematology, Utah Blood and Marrow Transplant and Myeloma Program
🇺🇸Salt Lake City, Utah, United States
University of Maryland, Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Ghent University Hospital
🇧🇪Ghent, Belgium
AZ Sint-Jan
🇧🇪Brugge, Belgium
Karolinska University Hospital
🇸🇪Huddinge, Sweden
Hematology Clinic Cancer Division, Skåne University Hospital
🇸🇪Lund, Sweden