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Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma



Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma

For Condition: Multiple Myeloma
Status: No longer recruiting
Sponsor(s): University of Arkansas ,
Synopsis: The purpose of this research is to study how helpful thalidomide is in controlling the myeloma disease and to study any side effect resulting from thalidomide.
Details: Patients will receive thalidomide in the oral form (by mouth). Then the dose of thalidomide will be increased each week until week 7 as long as there are no significant side effects. After week 7, patients will continue to receive thalidomide as long as there is no toxicity requiring the treatment to be stopped and as long as there is no evidence of rapid tumor growth during the treatment with thalidomide. Routine physical examinations and blood tests will be done to monitor the effect of treatment and the toxicities encountered, if any, and provide the available treatments for side effects accordingly. Blood tests will be done once a month for the first six months of receiving thalidomide.
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: - All patients must have a confirmed diagnosis of previously treated, active multiple myeloma - Myeloma protein should be evident from which to evaluate response - Must be 18 years of age or older - Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug - Patients may be anemic or thrombocytopenic provided this is felt to be due to extensive marrow involvement with myeloma - Patients must have a total white blood cell count of 2,000 K/uL Exclusion Criteria: - Patients must not have an active infection requiring parenteral antibiotics - No other concurrent therapy for myeloma is permitted while on Thalidomide
Total Enrollment: 250

Location and Contact Information:

Overall Study Official:
BartBarlogie,  Principal Investigator,  UAMS

University of Arkansas for Medical Sciences/MIRT
Little Rock,  Arkansas,  72205
United States
 


Additional Information:
Study ID Numbers:  UARK 98-003; 
Study Start Date: February 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083577

Other Multiple Myeloma Studies:
1. Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma

2. Donor Th2 Cells to Prevent Graft-Versus-Host Disease in Bone Marrow Transplants

3. Immunotherapy in Treating Patients Who Are Undergoing Bone Marrow or Peripheral Stem Cell Transplantation

4. Tipifarnib in Treating Patients With Advanced Hematologic Cancer

5. Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation

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