Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma

Phase 2

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00083577
• Lead Sponsor: University of Arkansas

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, 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.

Study Timeline

• Study Start: 1998-02
• Study First Submitted: 2004-05-25
• Study First Submitted QC: 2004-05-26
• Study First Posted: 2004-05-27
• Study Completion: 2005-05
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-01
• Last Update Posted: 2010-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine tumor response, overall and progression free survival following thalidomide therapy in patients with multiple myeloma

Secondary Outcome Measures

Name	Time	Method
To determine toxicities associated with thalidomide in patients with multiple myeloma

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences/MIRT; 🇺🇸 Little Rock, Arkansas, United States