Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma
UARK 98-003, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Multiple Myeloma
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Feb 1998
Longer than P75 for phase_2 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1998
CompletedFirst Submitted
Initial submission to the registry
May 25, 2004
CompletedFirst Posted
Study publicly available on registry
May 27, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedJuly 2, 2010
July 1, 2010
May 25, 2004
July 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine tumor response, overall and progression free survival following thalidomide therapy in patients with multiple myeloma
Secondary Outcomes (1)
To determine toxicities associated with thalidomide in patients with multiple myeloma
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients must not have an active infection requiring parenteral antibiotics
- No other concurrent therapy for myeloma is permitted while on Thalidomide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, 72205, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bart Barlogie, M.D.
UAMS
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 25, 2004
First Posted
May 27, 2004
Study Start
February 1, 1998
Study Completion
May 1, 2005
Last Updated
July 2, 2010
Record last verified: 2010-07