Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Pamidronate, Thalidomide, refractory myeloma, bisphosphonates, Aredia
Brief summary
The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate is in controlling multiple myeloma and to study any side effects that may be experienced.
Detailed 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.
Interventions
DRUGPamidronate
DRUGThalidomide
Sponsors
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have a diagnosis of Multiple myeloma with poor hematopoietic reserve (platelet count \<100,000 OR inability to collect adequate PBSC to support autologous transplant (4X106 CD34+cells/kg OR WBC \<2,000) * Patients must not be eligible for UARK 98-035 * Patients must be at least 6 weeks beyond previous chemotherapy * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of combination treatment with Thalidomide and Pamidronate in patients with refractory myeloma and poor hematopoietic stem cell reserve. Effectiveness will be based on the estimate of the objective response rate (CR + PR). | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effect of these agents on disease parameters, specifically on time to disease progression and overall survival. | — |
Countries
United States
Outcome results
None listed