Back to resultsAnti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Thalidomide, Anti-Angiogenesis
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
Sites / Locations
- University of Arkansas for Medical Sciences/MIRT
Outcomes
Primary Outcome Measures
To determine tumor response, overall and progression free survival following thalidomide therapy in patients with multiple myeloma
Secondary Outcome Measures
To determine toxicities associated with thalidomide in patients with multiple myeloma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00083577
Brief Title
Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma
Official Title
UARK 98-003, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Arkansas
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Thalidomide, Anti-Angiogenesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Primary Outcome Measure Information:
Title
To determine tumor response, overall and progression free survival following thalidomide therapy in patients with multiple myeloma
Secondary Outcome Measure Information:
Title
To determine toxicities associated with thalidomide in patients with multiple myeloma
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Barlogie, M.D.
Organizational Affiliation
UAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences/MIRT
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Links:
URL
http://myeloma.uams.edu
Description
Myeloma Institute for Research & Therapy website
Learn more about this trial
Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma
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