|
Study of Combination PS-341 and Thalidomide in Multiple Myeloma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Study of Combination PS-341 and Thalidomide in Multiple Myeloma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Study of Combination PS-341 and Thalidomide in Multiple Myeloma Clinical research trials and Study of Combination PS-341 and Thalidomide in Multiple Myeloma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Study of Combination PS-341 and Thalidomide in Multiple Myeloma. Study of Combination PS-341 and Thalidomide in Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Study of Combination PS-341 and Thalidomide in Multiple Myeloma clinical trial. Test subjects typically receive the most effective healthcare possible for their Study of Combination PS-341 and Thalidomide in Multiple Myeloma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Study of Combination PS-341 and Thalidomide in Multiple Myeloma  Study of Combination PS-341 and Thalidomide in Multiple Myeloma
Study of Combination PS-341 and Thalidomide in Multiple Myeloma
For Condition: Multiple Myeloma
Status: Recruiting
Sponsor(s): University of Arkansas , Millennium Pharmaceuticals,Celgene Corporation
Synopsis: The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate doses of PS-341 and thalidomide in the combination.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - History of histologically documented multiple myeloma with relapsed or resistant disease, defined as previously treated with/without autologous stem cell transplantation and is either relapsing or is resistant after > 1 line of prior therapy for myeloma - Patients can not be eligible for MTRC phase III protocols of higher priority - Performance status of greater than or equal to 2 as per SWOG scale - Patients must have an absolute neutrophil count > 750/mm3, and a platelet count greater than or equal to 25,000/mm3 - No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval - Pregnant or nursing women may not participate - Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations Exclusion Criteria: - Chemotherapy or radiotherapy received within the previous 2 weeks - Prior Treatment of PS-341 - Significant neurotoxicity, defined as grade greater than or equal to 2 neurotoxicity per NCI Common Toxicity Criteria - POEMS Syndrome - Non-secretory multiple myeloma - Active infection requiring antibiotics - Clinically significant hepatic dysfunction in the absence of liver metastases as noted by bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis - New York Hospital Association (NYHA) Class III or Class IV heart failure - Myocardial infarction within the last 6 months - Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol - Severe renal dysfunction defined as a creatinine clearance < 20 cc/min - Absolute neutrophil count < 750/mm3, and a platelet count < 25,000/mm3 - Pregnant or potential for pregnancy - Breast-feeding
Total Enrollment: 80
Location and Contact Information:
Overall Study Official:
BarlogieBarthel, Principal Investigator, University of Arkanas for Medical Sciences website
University of Arkansas for Medical Sciences/MIRT *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Mark Mosby 501-296-1503
Additional Information:
Study ID Numbers: UARK 2001-37;
Study Start Date: December 2001
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083460
Other Multiple Myeloma Studies:
1. Stem Cell Transplant for Patients with Blood Malignancy Using Donors and Less Toxic Chemotherapy with CAMPATH 1H
2. Donor Th2 Cells to Prevent Graft-Versus-Host Disease in Bone Marrow Transplants
3. Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
4. Combination Bisphosphonate and Anti-Angiogenesis Therapy with Pamidronate and Thalidomide
5. Safety Study of AP23573 in Patients with Advanced, Refractory or Recurrent Malignancies
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Arkansas Clinical Trials
Other Little Rock Clinical Trials
Study of Combination PS-341 and Thalidomide in Multiple Myeloma
|
|
|
|
|
|
|
|
