Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma

The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any side effects.

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.

Inclusion Criteria:

• Patients must have a diagnosis of Smoldering or Indolent myeloma
• All patients must be informed of the investigational nature of this study and must sign a written informed consent in accordance with UAMS Human Research Advisory Committee and federal guidelines.

Exclusion Criteria:

• Prior bisphosphonate therapy within 30 days prior to study entry.
• Serum creatinine > 5 mg/dl, ascites, or serum direct bilirubin > 2.5 mg/dl.
• Prior plicamycin or calcitonin within 2 weeks of study entry.
• Severe cardiac disease, unstable thyroid disease, or epilepsy.
• Prior radiation therapy to > 20% of the skeleton.