Status:
TERMINATED
Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple Myeloma
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Collaborating Sponsors:
Kyowa Hakko Kirin Pharma, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study will test the ability of a specially designed monoclonal antibody to destroy multiple myeloma cells. This antibody is unique in its ability to promote the death of multiple myeloma cells by...
Detailed Description
BIW-8962 is a monoclonal antibody which targets the GM-2 ganglioside which is expressed at high levels on the surface of multiple myeloma cells. This is a Phase 1/2 study design. The Phase 1 component...
Eligibility Criteria
Inclusion
- Relapsed or refractory myeloma
- M-protein in serum and/or urine by IMWG criteria.
- Bone marrow plasma cells or plasmacytoma
- Related organ or tissue impairment (CRAB)
- Subjects without detectable M protein are eligible if they have an abnormal serum free light chain ratio (FLC) or if they have at least 10% plasma cells in the bone marrow
Exclusion
- Ongoing infection
- Cardiac disease
- Uncontrolled hypertension
- Active liver disease
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00775502
Start Date
October 1 2008
End Date
October 1 2011
Last Update
April 25 2024
Active Locations (5)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
2
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
3
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-2014
4
Duke Medical Center
Durham, North Carolina, United States, 27705