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Trial registered on ANZCTR


Registration number
ACTRN12606000433505
Ethics application status
Not yet submitted
Date submitted
2/10/2006
Date registered
10/10/2006
Date last updated
29/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A Three-Stage Phase I/II Dose-Escalation Study of High-Dose Melphalan with Palifermin for Patients with Multiple Myeloma
Scientific title
A Three-Stage Phase I/II Dose-Escalation Study of High-Dose Melphalan with Palifermin for Patients with Multiple Myeloma to Determine a New Maximum Tolerated Dose (MTD) of Melphalan for use in Autografting
Secondary ID [1] 308 0
Australasian Leukaemia and Lymphoma Group (ALLG): ALLG MM9
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple myeloma 1405 0
Condition category
Condition code
Cancer 1500 1500 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Palifermin 60mcg/kg/day intravenous bolus, for 3 consecutive days before and 3 consecutive days after melphalan. Palifermin is given for 3 consecutive days prior to and 3 consecutive days after Stem Cell infusion. Take the stem cell infusion day as day 0, Palifermin is given on days -5, -4, -3. Melphalan is given on day -1, and Palifermin is given again on day +1, +2, +3. Melphalan dose escalating from starting dose of 220 mg/m2 given as an intravenous bolus. Each patient is given one dose of high dose Melphalan as conditioning prior to Autologous Stem Cell Transplant. Stage 1 of this trial is to establish Maximum Tolerated Dose (MTD) and so each cohort of patients will be given one dose each, and doses will be escalated cohort by cohort until MTD is reached. Pegfilgrastim 6mg by subcutaneous injection one day after stem cell infusion.
Intervention code [1] 1385 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Dose comparison

Outcomes
Primary outcome [1] 2071 0
To determine the maximum tolerated dose of intravenous melphalan when it is used in combination with palifermin for the treatment of multiple myeloma patients who fail to achieve complete remission with pre-transplant induction therapy. The occurrence of 2 grade 4 toxicities within a 4 or 8 person cohort will establish the MTD as the dose level below that cohort's dose level.
Timepoint [1] 2071 0
Patients will be observed for 4 weeks post transplant to identify any grade 4 non-haematological toxicity.
Secondary outcome [1] 3575 0
To determine the complete response rate achieved with the maximum tolerated dose of intravenous melphalan when it is used in combination with palifermin for the treatment of multiple myeloma patients who fail to achieve either 1) partial remission or 2) complete remission with pre-transplant induction therapy.
Timepoint [1] 3575 0
Secondary outcome [2] 3576 0
To characterize the rate of neutrophil engraftment following high-dose melphalan conditioned autologous stem cell transplant in patients with multiple myeloma being treated with palifermin.
Timepoint [2] 3576 0
Secondary outcome [3] 3577 0
Disease response will be measured at 3months post transplant when a bone marrow, biochemistry and serum and urine paraprotein assessments will be performed.
Timepoint [3] 3577 0
Secondary outcome [4] 3578 0
Neutrophil engraftment will be monitored with daily blood counts, post transplant until engraftment (neutrophils greater than 0.5x10^9/L) is established.
Timepoint [4] 3578 0

Eligibility
Key inclusion criteria
Diagnosis of multiple myeloma.-No more than 12 months total prior standard-dose chemotherapy.-No previous high-dose chemotherapy or autologous transplantation procedure.-Normal liver function->2.0 x 106 CD34+ cells/kg bodyweight available for reinfusion.-ECOG performance status <3-Have achieved less than Complete Response with a recognised induction protocol-No contraindication to the use of any of the study drugs, including knownsensitivity to E coli-derived preparations.-Written informed consent.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with monoclonal gammopathy of undetermined significance-Patients whose general condition makes them unsuitable for intensivetreatment-Active infections or other illnesses that precludes chemotherapyadministration or patient compliance.-Serum creatinine >0.18mMol/L.-Pregnant or lactating women.

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
dose escalation groups
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
1/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1635 0
Commercial sector/Industry
Name [1] 1635 0
Amgen Australia
Country [1] 1635 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Country
Australia
Secondary sponsor category [1] 1442 0
None
Name [1] 1442 0
nil
Address [1] 1442 0
Country [1] 1442 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
To determine how much the melphalan dose used as conditioning for autologous stem cell transplant can be increased when given with Palifermin, and how many more patients can achieve the best response on this increased dose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27612 0
Address 27612 0
Country 27612 0
Phone 27612 0
Fax 27612 0
Email 27612 0
Contact person for public queries
Name 10574 0
Ms Nola Kennedy
Address 10574 0
Myeloma Research Group
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 10574 0
Australia
Phone 10574 0
+61 3 92762217
Fax 10574 0
+61 3 92766531
Email 10574 0
[email protected]
Contact person for scientific queries
Name 1502 0
Associate Professor Andrew Spencer
Address 1502 0
Myeloma Research Group
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 1502 0
Australia
Phone 1502 0
+61 3 92763392
Fax 1502 0
+61 3 92762298
Email 1502 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.