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)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 269 patients with newly diagnosed multiple myeloma using low-dose thalidomide, prednisolone and zoledronic acid versus prednisolone and zoledronic acid in a randomised trial Demographic data, diagnostic data, treatment data, outcome data
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Source Study


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 ....
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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 ....
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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.

Can healthy volunteers participate?




Sample Size    269

Min. age    17 Years

Max. age    No limit

Sex    Both males and females

Condition category    Multiple Myeloma

Condition code    Cancer


Intervention code Treatment: Drugs

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.


Control group Active

Prednisolone and Zoledronic acid.


Outcome: 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.
Timepoint: Time to progression is measured by monitoring patients from the time of starting maintenance therapy until a patient has progressive disease.

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data for all data collected during the trial

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the sponsor ALLG on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.

Available for what types of analyses?

Any type of analysis. Proposals will be assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see