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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01025206

Enrollment

Registered

2009-12-03

Start date

2009-12-31

Completion date

2013-02-28

Last updated

2013-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, monoclonal antibody, safety, pharmacokinetic

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.

Interventions

BIOLOGICALBI-505

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Belgium, Denmark, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026