A Study of a Human Anti-Intercellular Adhesion Molecule-1 Monoclonal Antibody, in Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioInvent International AB
ClinicalTrials.gov Identifier:
NCT01025206
First received: December 1, 2009
Last updated: March 14, 2013
Last verified: October 2012

December 1, 2009
March 14, 2013
December 2009
February 2013   (final data collection date for primary outcome measure)
Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests [ Time Frame: four weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01025206 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Biological: BI-505
Anti-ICAM-1 monoclonal antibody given as a i.v infusion every second week for four weeks,
Experimental: BI-505
Intervention: Biological: BI-505
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Denmark,   Sweden
 
NCT01025206
BI-505-01
Yes
BioInvent International AB
BioInvent International AB
Not Provided
Principal Investigator: Guido Tricot, MD, PhD, Prof. University of Utah
BioInvent International AB
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP