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.

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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000700033

Enrollment

Registered

2010-08-24

Start date

2010-07-29

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This phase II study is a single centre open-label, multiple dose study intended to determine the preliminary efficacy of MDX-1097. Up to 27 previously treated kappa light chain restricted multiple myeloma subjects with stable measurable disease will be enrolled in the study. Weekly i.v. infusion of MDX-1097 for a total of 8 weeks at a dose level of 10 mg/kg is planned for all subjects. Subjects will be assigned to the clinical trial in the order of study entry. The study will consist of 3 phases: Screening Phase, Treatment Phase and the Follow-up Phase.

Interventions

Up to 27 subjects who meet the eligibility criteria will be administered MDX-1097 at a dose of 10 mg/kg via an intravenous (i.v.) infusion administered over 90 minutes every seven days to a total of 8 doses.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Outcome results