Trial purpose
Cancer treatment
Tumor type
Haematological
Age
17+
Clinical summary
Summary
This is a randomised, open label trial assessing 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.
Eligibility
Inclusion
- 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
- 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.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Australasian Leukaemia and Lymphoma Group (ALLG)
Scientific Title
A multicentre randomised phase III study of low-dose thalidomide, prednisolone and zoledronic acid versus prednisolone and zoledronic acid to assess survival post-ASCT maintenance therapy in patients with multiple myeloma
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