Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: Thalidomide

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. 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 Criteria:

• Patients must not have an active infection requiring parenteral antibiotics

• No other concurrent therapy for myeloma is permitted while on Thalidomide