Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000700033
Ethics application status
Approved
Date submitted
10/08/2010
Date registered
24/08/2010
Date last updated
24/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 252422 0
None
Universal Trial Number (UTN)
U1111-1116-4557
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 257930 0
Condition category
Condition code
Cancer 258100 258100 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256985 0
Treatment: Drugs
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258961 0
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.
Timepoint [1] 258961 0
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 [1] 265135 0
Characterization of the safety and tolerability of 8 weekly doses of MDX-1097 at a dose level of 10 mg/kg, including acute and chronic toxicities.
Timepoint [1] 265135 0
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, pharmacokinetic sampling, vital sign measurements, physical examinations, electrocardiogram (ECG) measurements, clinical laboratory testing, and the collection of adverse events.
Secondary outcome [2] 265136 0
Determination of multiple-dose pharmacokinetics of MDX-1097 in subjects.
Timepoint [2] 265136 0
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 and pharmacokinetic sampling
Secondary outcome [3] 265137 0
Measurement of immunogenicity of MDX-1097.
Timepoint [3] 265137 0
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 and immunogenicity sampling
Secondary outcome [4] 265138 0
Determination of the safety and response to MDX-1097 treatment. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Timepoint [4] 265138 0
After Day 94 post-infusion subjects will be assessed monthly for 12 months in the follow-up phase.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 257437 0
Commercial sector/Industry
Name [1] 257437 0
Immune System Therapeutics Limited
Country [1] 257437 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Immune System Therapeutics Limited
Address
Level 1, 645 Harris Street
Ultimo,
Sydney
NSW 2007
Country
Australia
Secondary sponsor category [1] 256666 0
None
Name [1] 256666 0
Address [1] 256666 0
Country [1] 256666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259462 0
The Alfred Hospital Drugs and Interventions Committee
Ethics committee address [1] 259462 0
The Alfred Hospital
Commercial Road
Prahran
Vic 3004
Ethics committee country [1] 259462 0
Australia
Date submitted for ethics approval [1] 259462 0
22/03/2010
Approval date [1] 259462 0
21/05/2010
Ethics approval number [1] 259462 0
80/10

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31504 0
Address 31504 0
Country 31504 0
Phone 31504 0
Fax 31504 0
Email 31504 0
Contact person for public queries
Name 14751 0
Kate Reed
Address 14751 0
Myeloma Research Group
The Alfred Hospital
Commercial Road
Melbourne
Vic 3004
Country 14751 0
Australia
Phone 14751 0
+61 3 92763571
Fax 14751 0
+61 3 9076 5531
Email 14751 0
K.Reed@alfred.org.au
Contact person for scientific queries
Name 5679 0
Professor Andrew Spencer
Address 5679 0
Malignant Haematology and Stem Cell Transplantation
Ground Floor South Block
Alfred Hospital
Commercial Road
Melbourne
Vic 3004
Country 5679 0
Australia
Phone 5679 0
+61 3 90763393
Fax 5679 0
+61 3 9076 5531
Email 5679 0
aspencer@netspace.net.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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