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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 1, 2009

Last Updated Date

March 14, 2013

Start Date ^ICMJE

December 2009

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01025206 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

Biological: BI-505

Anti-ICAM-1 monoclonal antibody given as a i.v infusion every second week for four weeks,

Study Arm (s)

Experimental: BI-505

Intervention: Biological: BI-505

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2013

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Denmark, Sweden

Administrative Information

NCT Number ^ICMJE

NCT01025206

Other Study ID Numbers ^ICMJE

BI-505-01

Has Data Monitoring Committee

Yes

Responsible Party

BioInvent International AB

Study Sponsor ^ICMJE

BioInvent International AB

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Guido Tricot, MD, PhD, Prof.

University of Utah

Information Provided By

BioInvent International AB

Verification Date

October 2012

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

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