Status:
COMPLETED
Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma
Lead Sponsor:
University of Arkansas
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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, pat...
Eligibility Criteria
Inclusion
- 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. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
- Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug
- Patients must have a total white blood cell count of 2,000 K/microliters. Patients may be anemic or thrombocytopenic provided this is felt to be due to extensive marrow involvement with myeloma
- Patients must have adequate liver function as demonstrated by a direct bilirubin of \< or = 2.0 mg/dL.
Exclusion
- Patients must not have an active infection requiring parenteral antibiotics
- No other concurrent therapy for myeloma is permitted while on Thalidomide
Key Trial Info
Start Date :
February 1 1998
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00083577
Start Date
February 1 1998
End Date
May 1 2005
Last Update
July 2 2010
Active Locations (1)
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1
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205