drugset / Trial / NCT00775502

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

NCT00775502 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2008-10
Primary completion
2011-05
Completion
2011-10

Outcome

Outcome not reported

Stopped: “lack of efficacy in Multiple myeloma”

Drugs

EvaluationDrugModalityDoseRoute
Subject BIW-8962 Monoclonal antibody 0.03 mg/kg Intravenous
Subject BIW-8962 Monoclonal antibody 0.1 mg/kg Intravenous
Subject BIW-8962 Monoclonal antibody 0.3 mg/kg Intravenous
Subject BIW-8962 Monoclonal antibody 1 mg/kg Intravenous
Subject BIW-8962 Monoclonal antibody 3 mg/kg Intravenous
Subject BIW-8962 Monoclonal antibody 10 mg/kg Intravenous

Indications