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Trial registered on ANZCTR


Registration number
ACTRN12608000336381
Ethics application status
Approved
Date submitted
2/07/2008
Date registered
16/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Open-label Phase I Study of the Safety and Efficacy of MDX-1097 in the Treatment of Previously Treated Kappa Light Chain Restricted Multiple Myeloma Patients with Stable Measurable Disease
Scientific title
An Open-label Phase I Study of the Safety and Efficacy of MDX-1097, an human IgG1k chimeric monoclonal antibody, in the Treatment of Previously Treated Kappa Light Chain Restricted Multiple Myeloma Patients with Stable Measurable Disease to determine the Safety, Tolerability and Maximum Tolerated Dose
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple myeloma 3365 0
Condition category
Condition code
Cancer 3518 3518 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a Phase I study of MDX-1097 an IgG1k chimeric monoclonal antibody. Up to 30 previously treated multiple myeloma patients with stable measurable disease will be enrolled in the study. Five dose levels are planned: 0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, 10 mg/kg and 30 mg/kg per dose will be administered as a single intravenous infusion. Patients will be assigned to a dose level in the order of study entry.
Intervention code [1] 3096 0
Treatment: Drugs
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4418 0
To determine the safety and tolerability of MDX-1097. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Comparison of vital sign measurements, physical examination assessments, Eastern Cooperative Oncology Group (ECOG) performance assessments, 12 lead electrocardiogram (ECG), clinical laboratory tests for haematology, clinical chemistry, urinalysis and creatinine clearance and changes in concomitant therapy from screening phase (baseline) to study completion (day 45)
Timepoint [1] 4418 0
Patients will be observed for 45 days post a single intravenous dose for any adverse event.
Secondary outcome [1] 7457 0
To determine the maximum tolerated dose of MDX-1097.
Timepoint [1] 7457 0
Dose limiting toxicities will be observed for 2 weeks post a single infusion.
>Grade 3 non-hematological toxicity excluding tumor flare
>Grade 4 Hematological toxicity
>Grade 4 infusion toxicity

Eligibility
Key inclusion criteria
Diagnosis of kappa light chain restricted multiple myeloma with stable measurable disease.
Serum paraprotein of > 5 g/L, 24 hour urinary light chain excretion of > 200 mg, or demonstration of excess serum free kappa light chains and an abnormal kappa:lambda light chain ratio.
Patients on maintenance therapy for multiple myeloma
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-measurable disease by serological measurement, serum free kappa light chains > 250 mg/L, active infections, pregnant or lactating women, any other active malignancy, patients on other investigational agents.

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
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 3551 0
Commercial sector/Industry
Name [1] 3551 0
Immune System Therapeutics
Address [1] 3551 0
Level 8, UTS Building 10
235 Jones Street
Ultimo NSW 2007
Country [1] 3551 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Immune System Therapeutics
Address
Level 8, UTS Building 10
235 Jones Street
Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 3189 0
None
Name [1] 3189 0
Address [1] 3189 0
Country [1] 3189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5593 0
The Alfred Hospital Drugs and Interventions Committee
Ethics committee address [1] 5593 0
The Alfred Hospital
Commercial Road
Melbourne
Ethics committee country [1] 5593 0
Australia
Date submitted for ethics approval [1] 5593 0
19/11/2007
Approval date [1] 5593 0
01/04/2008
Ethics approval number [1] 5593 0
267/07

Summary
Brief summary
This Phase I study is a single-center, open-label, between-patient, single ascending dose study intended to determine the safety, tolerability and maximum tolerated dose (MTD) of MDX-1097.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28725 0
Address 28725 0
Country 28725 0
Phone 28725 0
Fax 28725 0
Email 28725 0
Contact person for public queries
Name 11882 0
Kate Reed
Address 11882 0
Myeloma Research Group Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 11882 0
Australia
Phone 11882 0
+61 3 92763571
Fax 11882 0
Email 11882 0
K.Reed@alfred.org.au
Contact person for scientific queries
Name 2810 0
Dr Andrew Spencer
Address 2810 0
Myeloma Research Group, The Alfred hospital, Commercial Road, Melbourne, VIC3004
Country 2810 0
Australia
Phone 2810 0
+61 3 90763393
Fax 2810 0
+61 3 90762298
Email 2810 0
aspencer@netspace.net.au

No information has been provided regarding IPD availability
Summary results
No Results