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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025206
• Other study ID #: BI-505-01
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2009
• Last updated: March 14, 2013
• Start date: December 2009
• Est. completion date: February 2013

Study information

• Verified date: October 2012
• Source: BioInvent International AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSweden: Swedish Medicines Product AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan	Brugge
Belgium	Ghent University Hospital	Ghent
Denmark	Rigshospitalet	Copenhagen
Sweden	Karolinska University Hospital	Huddinge
Sweden	Hematology Clinic Cancer Division, Skåne University Hospital	Lund
United States	University of Maryland, Greenebaum Cancer Center	Baltimore	Maryland
United States	University of Utah Health Sciences Center, Department of Medicine, Division of Hematology, Utah Blood and Marrow Transplant and Myeloma Program	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
BioInvent International AB

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests		four weeks	Yes