Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma
This study has been completed.
Sponsor:
University of Arkansas
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083577
First received: May 25, 2004
Last updated: July 1, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | UARK 98-003, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Multiple Myeloma |
Resource links provided by NLM:
Further study details as provided by University of Arkansas:
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
| Estimated Enrollment: | 250 |
| Study Start Date: | February 1998 |
| Estimated Study Completion Date: | May 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083577
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Sciences/MIRT | |
| Little Rock, Arkansas, United States, 72205 | |
Sponsors and Collaborators
University of Arkansas
Investigators
| Principal Investigator: | Bart Barlogie, M.D. | UAMS |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00083577 History of Changes |
| Other Study ID Numbers: | UARK 98-003 |
| Study First Received: | May 25, 2004 |
| Last Updated: | July 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
Multiple Myeloma Thalidomide Anti-Angiogenesis |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013