NCT01025206
Completed
Phase 1
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
ConditionsMultiple Myeloma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- BioInvent International AB
- Enrollment
- 35
- Locations
- 7
- Primary Endpoint
- Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests
Time Frame: four weeks
Study Sites (7)
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