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

March 14, 2013 updated by: BioInvent International AB

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan
      • Ghent, Belgium, 9000
        • Ghent University Hospital
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • Sweden
      • Huddinge, Sweden, 141 86
        • Karolinska University Hospital
      • Lund, Sweden, SE-22185
        • Hematology Clinic Cancer Division, Skåne University Hospital
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Greenebaum Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84132-2408
        • University of Utah Health Sciences Center, Department of Medicine, Division of Hematology, Utah Blood and Marrow Transplant and Myeloma Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests
Time Frame: four weeks
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioInvent International AB

Investigators

  • Principal Investigator: Guido Tricot, MD, PhD, Prof., University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BI-505-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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