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

BioInvent International

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Biological: BI-505

Study type: Interventional

Funder types: Industry

Identifiers

NCT01025206

BI-505-01

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

BI-505

Experimental group

Treatment:

Biological: BI-505