Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000116224
Ethics application status
Not yet submitted
Date submitted
8/01/2009
Date registered
18/02/2009
Date last updated
29/04/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to investigate whether the combination of Mozobil and Neulasta is safe and effective for mobilization of blood stem cells for the treatment of lymphoma and multiple myeloma
Scientific title
A pilot study investigating the combination of Mozobil® plus Neulasta® for Hematopoietic progenitor Cell (HPC-A) Mobilization in Patients with Lymphoma or Multiple Myeloma
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 4179 0
Multiple myeloma 4180 0
Condition category
Condition code
Cancer 4388 4388 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 4389 4389 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 4390 4390 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pegfilgrastim (Neulasta®) 6mg subcutaneous injection once only on day 1,
Plerixafor (Mozobil®) 240ug/kg subcutaneous injection on day 3. Additional plerixafor doses (240 ug/kg) days 4, 5 and 6 if target apheresis yields not reached.
Intervention code [1] 3898 0
Treatment: Drugs
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5267 0
Toxicity/adverse events. The National Cancer Institute (USA) Common Toxicitiy Criteria for Adverse Eevents (CTCAE) version 3 is the instrument used to designate and grade adverse events.
Timepoint [1] 5267 0
Baseline, day 3, day 4 , day 11 and day 28 (end) of study
Primary outcome [2] 5268 0
Peripheral blood CD34+ cell counts. Measured by flow cytometry cytometric assessment of cells expressing the CD34+ antigen.
Timepoint [2] 5268 0
Baseline, then daily from day 3 to day 7 or until target CD34+ cell yield is reached (whichever occurs first)
Secondary outcome [1] 8880 0
Mobilization efficacy defined as:
"successful" (collection of a minimum > 2x10^6/kg CD34+ cells),
"optimal" (collection of > 5x10^6/kg CD34+ cells), "unsuccessful" (collection of <2x10^6/kg CD34+ cells) or "mobilization failure" (patient never achieved a peripheral blood CD34+ count of > 5x10^6/L)
Timepoint [1] 8880 0
Mobilization status will be assessed at day 7

Eligibility
Key inclusion criteria
1. Histologically proven multiple myeloma or lymphoproliferative disease
2. Absolute neutrophil count between 1.5 and 10.0 x 10^9/L
3. Adequate renal function: calculated creatinine clearance >/= 30 ml/min
4. Eastern Cooperative Oncology Group (ECOG) performance status >/=2
5. Life expectancy of at least 2 months
6. Able to give written informed consent
7.Patient able to make arrangements for injection of study drugs (self, family member, visiting nurse, etc)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active infection (fever due to B symptoms in lymphoma patients will not exclude a patient)
2. Pregnancy or breast feeding.
3. Significant non-malignant disease including Human Immunodeficieny Virus (HIV) infection, uncontrolled hypertension (diastolic blood pressures > 115 mmHg), unstable angina.
4. Known allergy to E.coli-derived products
5. Patients predicted to be ‘adequate mobilizers must have the absence of specific risk factors for poor mobilization

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
6 patients must be prior failed mobilizers, the remaining 6 must be anticipated adequate mobilizers (no risk factors for failed mobilization)

Patients will be enrolled from a list of prospective patients identified during the Bone Marrow Transplant Meeting at Peter MacCallum Cancer Centre.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4361 0
Commercial sector/Industry
Name [1] 4361 0
Genzyme Australasia Pty Ltd
Country [1] 4361 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrews Place
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 3928 0
None
Name [1] 3928 0
Address [1] 3928 0
Country [1] 3928 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6411 0
Ethics committee address [1] 6411 0
Ethics committee country [1] 6411 0
Date submitted for ethics approval [1] 6411 0
19/01/2009
Approval date [1] 6411 0
Ethics approval number [1] 6411 0

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

Contacts
Principal investigator
Name 35078 0
Address 35078 0
Country 35078 0
Phone 35078 0
Fax 35078 0
Email 35078 0
Contact person for public queries
Name 12425 0
Dr Kirsten Herbert
Address 12425 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 12425 0
Australia
Phone 12425 0
+ 61 3 9656 1111
Fax 12425 0
Email 12425 0
kirsten.herbert@petermac.org
Contact person for scientific queries
Name 3353 0
Dr Kirsten Herbert
Address 3353 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 3353 0
Australia
Phone 3353 0
+ 61 3 9656 1111
Fax 3353 0
Email 3353 0
kirsten.herbert@petermac.org

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.