None listed
Conditions
Brief summary
Multiple myeloma is a cancer of the blood for which there is still no cure. A standard treatment for myeloma is high dose therapy followed by autologous stem cell infusion (ASCT). It is thought that the better the response achieved by ASCT, the longer a patient will remain stable. Thalidomide has been shown to have potent anti-myeloma activity and this trial will test that if it is added to a treatment regimen, a longer time of disease stability will be achieved. Information on the tolerability of thalidomide will be collected and also if it makes a difference in overall survival.
Interventions
A multi-institutional study to assess if 12 months of 200mg daily of thalidomide added to a maintenance regimen of oral 50mg prednisolone every second day and monthly intravenous infusion of zoledronic acid will improve survival in myeloma patients post ASCT. Eligible patients will be randomised to receive thalidomide or not.
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of multiple myeloma responsive to standard anti-myelomatous therapy • No more than 12 months total prior standard-dose chemotherapy.• No previous high-dose chemotherapy or autologous transplantation procedure.• Eastern Cooperative Oncology Group performance status 0, 1, or 2 • Normal liver and kidney function • =2.0 x 106/kg CD34+ stem cells available for infusion.• No contraindication to the use of any of the study drugs, including known sensitivity to E coli derived preparations.• Written informed consent.
Exclusion criteria
• Patients with monoclonal gammopathy of uncertain significance or indolent multiple myeloma.• Patients with progressive multiple myeloma pre or post-ASCT.• Patients whose general condition makes them unsuitable for intensive treatment • Active infections or other illnesses that would preclude conditioning chemotherapy or maintenance therapy administration or patient compliance.• Pregnant or lactating women.
Outcome results
None listed