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CompletedNCT01025206Updated Mar 15, 2013

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

A Phase 1 interventional study of BI-505 in Multiple Myeloma, sponsored by BioInvent International AB. Completed at 7 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-15.

Sponsored by BioInvent International AB · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
  • monoclonal antibody
  • safety
  • pharmacokinetic
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 35 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

BioInvent International AB is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Advanced Myeloma with measurable disease after at least 2 previous regimens.
  • Life expectancy > 3 months.
  • Performance status ECOG \< 2.

Exclusion criteria

Exclusion Criteria:

  • Prior antineoplastic therapy within 4 weeks prior to inclusion.
  • No high dose steroids within 7 days prior to screening.
  • Severe other conditions.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    BI-505

    Biological: BI-505

Interventions

  • BiologicalBI-505

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

06

What researchers measure

Primary outcomes

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

    Time frame: four weeks

07

Study locations

7 sites
  • University of Maryland, Greenebaum Cancer Center
    Baltimore, Maryland 21201, United States
  • University of Utah Health Sciences Center, Department of Medicine, Division of Hematology, Utah Blood and Marrow Transplant and Myeloma Program
    Salt Lake City, Utah 84132-2408, United States
  • AZ Sint-Jan
    Brugge, 8000, Belgium
  • Ghent University Hospital
    Ghent, 9000, Belgium
  • Rigshospitalet
    Copenhagen, 2100, Denmark
  • Karolinska University Hospital
    Huddinge, 141 86, Sweden
  • Hematology Clinic Cancer Division, Skåne University Hospital
    Lund, SE-22185, Sweden
08

References and documents

Publications

  • Hansson M, Gimsing P, Badros A, Niskanen TM, Nahi H, Offner F, Salomo M, Sonesson E, Mau-Sorensen M, Stenberg Y, Sundberg A, Teige I, Van Droogenbroeck J, Wichert S, Zangari M, Frendeus B, Korsgren M, Poelman M, Tricot G. A Phase I Dose-Escalation Study of Antibody BI-505 in Relapsed/Refractory Multiple Myeloma. Clin Cancer Res. 2015 Jun 15;21(12):2730-6. doi: 10.1158/1078-0432.CCR-14-3090. Epub 2015 Feb 24. PubMed 25712687 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01025206
Lead sponsor
BioInvent International AB
Responsible party
Sponsor
First posted
Dec 3, 2009
Start date
Dec 2009
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Mar 15, 2013

Study contacts

Guido Tricot, MD, PhD, Prof.
principal investigator · University of Utah

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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