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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AZ Sint-Jan, Bruges, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BI-505

Biological

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

Primary outcomes

Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests

Time frame: four weeks

Sponsors and collaborators

Lead sponsor

BioInvent International AB

Industry

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Dec 3, 2009
Registry last updated: Mar 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed