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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01025206
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
BioInvent International AB

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: BI-505 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BI-505 Biological: BI-505
Anti-ICAM-1 monoclonal antibody given as a i.v infusion every second week for four weeks,



Primary Outcome Measures :
  1. Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests [ Time Frame: four weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: October 2012

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