Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma

NCT ID: NCT00083577

Last Updated: 2010-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-02-28
• Study Completion Date: 2005-05-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Thalidomide

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Principal Investigators

Bart Barlogie, M.D.

Role: PRINCIPAL_INVESTIGATOR

UAMS

Locations

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, United States

Countries

United States

Related Links

http://myeloma.uams.edu

Myeloma Institute for Research \& Therapy website

Other Identifiers

UARK 98-003

Identifier Type: -

Identifier Source: org_study_id