A Phase II, Open-label, Multi-Dose Study of the Monoclonal Antibody MDX-1097 in Previously Treated Kappa Light Chain Restricted Multiple Myeloma Subjects with Stable Measurable Disease.
- Conditions
- Multiple MyelomaCancer - Myeloma
- Registration Number
- ACTRN12610000700033
- Lead Sponsor
- Immune System Therapeutics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this Phase II study is to assess the efficacy of MDX-1097 in previously treated multiple myeloma subjects with stable measurable disease. A decrease in serum biological parameters; M-protein, free light chain (FLC), malignant plasma cells in the bone marrow and active metabolic disease as evidenced by positron emission topography (PET) scan will be used to establish whether a partial response (PR), very good partial response (vPR), complete response (CR) or stringent complete response (sCR) to anti-tumour treatment has been achieved.[During the Treatment phase, subjects will be required to visit the Investigators office or clinic on study day 0, 7, 14, 21, 28, 35, 42, 49, 63, 79 and 94 for administration of study drug, response assessment, pharmacokinetic sampling, vital sign measurements, physical examinations, electrocardiogram (ECG) measurements, clinical laboratory testing, and the collection of adverse events.]
- Secondary Outcome Measures
Name Time Method