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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

four weeks

Safety Issue:

Yes

Principal Investigator

Guido Tricot, MD, PhD, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Utah

Authority:

United States: Food and Drug Administration

Study ID:

BI-505-01

NCT ID:

NCT01025206

Start Date:

December 2009

Completion Date:

February 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • monoclonal antibody
  • safety
  • pharmacokinetic
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
University of Maryland, Greenebaum Cancer Center Baltimore, Maryland  21201
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