A multicentre randomised phase III study of low-dose thalidomide, prednisolone and zoledronic acid versus prednisolone and zoledronic acid for post-autologous stem cell transplant (ASCT) maintenance therapy in patients with multiple myeloma (MM6)
- Conditions
- Multiple MyelomaCancer - Myeloma
- Registration Number
- ACTRN12607000382471
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 269
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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine whether the addition of low-dose thalidomide to alternate day prednisolone and zoledronic acid maintenance therapy post-ASCT for multiple myeloma (MM) patients improves progression-free survival.[ Time to progression is measured by monitoring patients from the time of starting maintenance therapy until a patient has progressive disease.]
- Secondary Outcome Measures
Name Time Method