Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

UARK 98-003, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00083577
• Other study ID #: UARK 98-003
• Status: Completed
• Phase: Phase 2
• First received: May 25, 2004
• Last updated: July 1, 2010
• Start date: February 1998
• Est. completion date: May 2005

Study information

• Verified date: July 2010
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Thalidomide

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences/MIRT	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine tumor response, overall and progression free survival following thalidomide therapy in patients with multiple myeloma
Secondary	To determine toxicities associated with thalidomide in patients with multiple myeloma

External Links

•   Myeloma Institute for Research & Therapy website