Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
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Details and patient eligibility
About
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.
Full description
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.
Enrollment
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Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
83 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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