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 (MM06)

Funding

Commercial sector/Industry,Amgen

Scientific enquiries

Associate Professor Andrew Spencer

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 .... 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.
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Key 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.• Wr .... 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.
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Key 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.