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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI-505

Group Type EXPERIMENTAL

BI-505

Intervention Type BIOLOGICAL

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

Interventions

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BI-505

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No