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Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083408
First received: May 24, 2004
Last updated: July 1, 2010
Last verified: July 2010

May 24, 2004
July 1, 2010
March 1998
Not Provided
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).
Same as current
Complete list of historical versions of study NCT00083408 on ClinicalTrials.gov Archive Site
To compare the effect of these agents on disease parameters, specifically on time to disease progression and overall survival.
Same as current
Not Provided
Not Provided
 
Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Pamidronate
  • Drug: Thalidomide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00083408
UARK 99-016
Not Provided
Not Provided
University of Arkansas
Not Provided
Principal Investigator: Athanasios Fassas, M.D. University of Arkansas
University of Arkansas
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP