Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple Myeloma

Stopped early · Phase 1

Conditions studied: Multiple Myeloma

In brief

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 processes known as antibody dependent cellular cytotoxicity (ADCC)and complement dependent cytotoxicity (CDC). The study is designed to determine both the optimal dose of the antibody to destroy multiple myeloma cells and frequency of dosing.

Key facts

Study ID

NCT00775502

Run by

Kyowa Kirin Co., Ltd.

People needed

23

Starts

2008-10-01

Expected to finish

2011-10-01

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Ongoing infection
• Cardiac disease
• Uncontrolled hypertension
• Active liver disease

Where it is running

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Robert H. Lurie Comprehensive Cancer Center, Northwestern University — Chicago, Illinois, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Duke Medical Center — Durham, North Carolina, United States
• Taussig Cancer Center- Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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