NCT01025206CompletedPhase 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
BioInvent International AB14 sites in 4 countries35 target enrollmentStarted: December 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- BioInvent International AB
- Enrollment
- 35
- Locations
- 14
- Primary Endpoint
- Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (14)
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