Primary Outcome Measures:
- To evaluate the effectiveness of combination treatment with Thalidomide and Pamidronate in patients with smoldering or indolent myeloma. Effectiveness will be based on the estimate of the objective response rate (CR + PR). [ Time Frame: life time ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare the effect of these agents on disease parameters, specifically on time to disease progression and overall survival. [ Time Frame: life time ] [ Designated as safety issue: No ]
Intervention Details:
Drug: Pamidronate
All patients will receive pamidronate at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles.
Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.
Drug: Thalidomide
reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met. Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose)
Drug: Zometa
All patients will receive zometa at a dose of 4 mg by continuous infusion every two weeks for 2 months. Disease will be reassessed after two cycles.
Those with stable disease or better will receive 4 mg every 4 weeks as maintenance therapy.
Recently laboratory research found that thalidomide can inhibit the formation of new blood vessels that are necessary for the growth and spread of cancer. In order to grow and increase in size tumors require new blood vessels to supply them with the necessary blood to grow. If we can prevent these new blood vessels feeding the tumor from being formed by using thalidomide we might slow or stop the growth of the tumor. This concept is called "anti-angiogenesis" It is hoped that thalidomide will slow or stop the growth myeloma. However, it cannot be guaranteed that you will benefit if you take part in this study. The treatment you receive may even be harmful.