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

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.

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.