This is a Phase II, Open-label, Multi-Dose Study of the Monoclonal Antibody MDX-1097 to determine the efficacy of the antibody in patients who have received prior treatment for myeloma and have kappa light chain restricted multiple myeloma with stable measurable disease.

Immune System Therapeutics Limited0 个研究点目标入组 27 人开始时间: 2010年8月24日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Subjects with kappa light-chain restricted multiple myeloma who have received at least one prior line of standard therapy, have achieved at least a minimal response (greater than 25% reduction in M-protein) and had stable measurable disease for at least 3 months prior to study enrollment will be eligible for the study. M protein of greater than or equal to 0.1 g/dL (1 g/L) and/or, 24 hour urinary light chain excretion of greater than or equal to 200 mg, and/or an abnormal free light chain assay (FreeLite assay) demonstrating an excess of kappa free light chains and a kappa: lambda abnormal ratio and/or presence of greater than 20% clonal plasma cells in the bone marrow and/or active skeletal disease based on radiological evaluation or appropriate medical imaging such as computed tomograpy-positron emission tomograpy (CT-PET) scan.

•A positive serum test for human anti-chimeric antibodies (HACA), as determined by Immune System Therapeutics (IST). Clinically relevant active infection or serious co-morbid medical conditions such as recent (6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, difficult to control cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, and cirrhosis. Any other active malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the subject has been disease-free for at least 5 years is permissible. Any active or chronic significant infection. Active human immunodeficiency virus (HIV) or hepatitis A, B, or C infection. Pregnant or lactating.

发起方

Immune System Therapeutics Limited