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

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Pharma, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

• 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 Criteria:

• Ongoing infection

• Cardiac disease

• Uncontrolled hypertension

• Active liver disease