None listed
Conditions
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.
Interventions
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 hi
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.
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed