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Combination Bisphosphonate and Anti-Angiogenesis Therapy with Pamidronate and Thalidomide



Combination Bisphosphonate and Anti-Angiogenesis Therapy with Pamidronate and Thalidomide

For Condition: Multiple Myeloma
Status: Recruiting
Sponsor(s): University of Arkansas , Celgene Corporation
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional,Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 100

Location and Contact Information:

Overall Study Official:
GiampaoloTalamo,  Principal Investigator,  University of Arkansas

University of Arkansas for Medical Sciences/MIRT *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Mark  Mosby 501-296-1503


Additional Information:
Study ID Numbers:
  UARK 98-036; 
Study Start Date: December 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083382

Other Multiple Myeloma Studies:
1. Safety Study of AP23573 in Patients with Advanced, Refractory or Recurrent Malignancies

2. Comparison of Antibody Therapies in Treating Patients With Graft- Versus-Host Disease That Does Not Respond to Steroid Therapy

3. PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

4. Total Therapy II

5. Treatment with Zometa in patients with breast cancer, multiple myeloma, and prostate cancer with cancer related bone lesions

Related Studies:

Other Multiple Myeloma Clinical Trials
Other Arkansas Clinical Trials
Other Little Rock Clinical Trials

Combination Bisphosphonate and Anti-Angiogenesis Therapy with Pamidronate and Thalidomide

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