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
  Purpose

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,

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025206

Locations
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
Belgium
AZ Sint-Jan
Brugge, Belgium, 8000
Ghent University Hospital
Ghent, Belgium, 9000
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sweden
Karolinska University Hospital
Huddinge, Sweden, 141 86
Hematology Clinic Cancer Division, Skåne University Hospital
Lund, Sweden, SE-22185
Sponsors and Collaborators
BioInvent International AB
Investigators
Principal Investigator: Guido Tricot, MD, PhD, Prof. University of Utah
  More Information

No publications provided

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
safety
pharmacokinetic

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

ClinicalTrials.gov processed this record on April 16, 2014