Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000584437
Ethics application status
Approved
Date submitted
13/11/2007
Date registered
14/11/2007
Date last updated
21/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective, Single-Arm, Two-Stage, Open-Label, Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma
Scientific title
A Prospective, Single-Arm, Two-Stage, Open-Label, Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma
Secondary ID [1] 253051 0
CCL07001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or refractory multiple myeloma 2539 0
Condition category
Condition code
Blood 2638 2638 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CYT997 is administered as a 24-hour intravenous infusion at a dose of 202mg/m2 on days 1 and 8 of a 21 day cycle for up to three cycles
Intervention code [1] 2271 0
Treatment: Drugs
Comparator / control treatment
There is no control group in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3548 0
Overall response rate
Timepoint [1] 3548 0
Response will be measured after each cycle (ie every three weeks).
Secondary outcome [1] 5938 0
Time to progression (TTP)
Timepoint [1] 5938 0
Progression will be measured each cycle (ie every three weeks).
Secondary outcome [2] 5948 0
Number of cycles of CYT997 required to achieve maximal response.
Timepoint [2] 5948 0
Response will be measured each cycle (ie every three weeks). The number of cycles required to attain maximal response will be determined on an ongoing basis by comparison with data collected during treatment for that patient.
Secondary outcome [3] 5949 0
Overall survival.
Timepoint [3] 5949 0
Overall survival will be measured on an ongoing basis during the study and whilst the patient remains on CYT997 therapy.
Secondary outcome [4] 5950 0
Safety and tolerability
Timepoint [4] 5950 0
Safety and tolerability will be assessed on an ongoing basis during the patients' participation in the trial.

Eligibility
Key inclusion criteria
Diagnosis of multiple myeloma as per WHO (World Health Organisation) criteria.
Age 18 years or greater.
Patients must have received at least one but no more than 3 prior lines of myeloma therapy.
Patients must have failed to respond to the most recently administered anti-myeloma therapy or have demonstrably progressive disease by accepted clinical criteria.
Patients must have a life expectancy of at least 3 months.
ECOG (Eastern Co-operative Oncology Group) performance status <3.
Patients must be willing and able to given informed, written consent.
Patients must agree to use adequate contraceptive measures if indicated.
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with monoclonal gammopathy of undetermined significance.
Known or suspective hypersensitivity to CYT997.
Patient with uncontrolled intercurrent illness.
Patients who are pregnant or lactating.
Patient who have received other investigational agents within the preceding three weeks prior to starting therapy.
Patients with heart-attack or stroke within the preceding 6 months; unstable angina pectoris; history of diabetic retinopathy or major surgery in the preceding 30 days will be excluded.
Patients with a baseline prolongation of the QTc interval (QT interval corrected for heart rate) >450 msec.
Patients with impaired cardiac function or clinically significant cardiac disease.
Patients currently receiving treatment with medications known to prolong the QTc interval.

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
Completed
Date of first participant enrolment
Anticipated
1/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 492 0
3004

Funding & Sponsors
Funding source category [1] 2782 0
Commercial sector/Industry
Name [1] 2782 0
YM BioSciences Australia Pty Ltd
Country [1] 2782 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
YM BioSciences Australia Pty Ltd
Address
Level 2, 499 St Kilda Road, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 2514 0
None
Name [1] 2514 0
Address [1] 2514 0
Country [1] 2514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4705 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 4705 0
Ethics committee country [1] 4705 0
Australia
Date submitted for ethics approval [1] 4705 0
25/09/2007
Approval date [1] 4705 0
Ethics approval number [1] 4705 0
EC00315

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28174 0
Address 28174 0
Country 28174 0
Phone 28174 0
Fax 28174 0
Email 28174 0
Contact person for public queries
Name 11331 0
Dr Gregg Smith
Address 11331 0
Level 2, 499 St Kilda Road, Melbourne VIC 3004
Country 11331 0
Australia
Phone 11331 0
(03) 9926 0444
Fax 11331 0
Email 11331 0
[email protected]
Contact person for scientific queries
Name 2259 0
Dr Gregg Smith
Address 2259 0
Level 2, 499 St Kilda Road, Melbourne VIC 3004
Country 2259 0
Australia
Phone 2259 0
(03) 9926 0444
Fax 2259 0
Email 2259 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.