TerminatedPhase 1

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

Stopped: lack of efficacy in Multiple myeloma

United States23 participantsStarted 2008-10

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Serum M protein levels

Timeframe: one month

Trial details

NCT IDNCT00775502

SponsorKyowa Kirin Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-05

View on ClinicalTrials.gov More Multiple Myeloma trials