Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

Multiple Myeloma Clinical Trial

Official title:

UARK 99-016, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Multiple Myeloma and Poor Hematopoietic Stem Cell Reserve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00083408
• Other study ID #: UARK 99-016
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2004
• Last updated: July 1, 2010
• Start date: March 1998
• Est. completion date: May 2005

Study information

• Verified date: July 2010
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Pamidronate

• Thalidomide

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences/MIRT	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare the effect of these agents on disease parameters, specifically on time to disease progression and overall survival.

External Links

•   Myeloma Institute for Research & Therapy website