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

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

Condition Intervention Phase
Multiple Myeloma
Biological: BI-505
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by BioInvent International AB:

Primary Outcome Measures:
  • Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests [ Time Frame: four weeks ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: December 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI-505 Biological: BI-505
Anti-ICAM-1 monoclonal antibody given as a i.v infusion every second week for four weeks,


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025206

United States, Maryland
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Utah
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, 84132-2408
AZ Sint-Jan
Brugge, Belgium, 8000
Ghent University Hospital
Ghent, Belgium, 9000
Copenhagen, Denmark, 2100
Karolinska University Hospital
Huddinge, Sweden, 141 86
Hematology Clinic Cancer Division, Skåne University Hospital
Lund, Sweden, SE-22185
Sponsors and Collaborators
BioInvent International AB
Principal Investigator: Guido Tricot, MD, PhD, Prof. University of Utah
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BioInvent International AB
ClinicalTrials.gov Identifier: NCT01025206     History of Changes
Other Study ID Numbers: BI-505-01 
Study First Received: December 1, 2009
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration
Sweden: Swedish Medicines Product Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Medicines Agency

Keywords provided by BioInvent International AB:
Multiple Myeloma
monoclonal antibody

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 27, 2016