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PS-341 in Treating Patients With Refractory or Progressive 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 PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma Clinical research trials and PS-341 in Treating Patients With Refractory or Progressive 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 PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma. PS-341 in Treating Patients With Refractory or Progressive 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 PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma clinical trial. Test subjects typically receive the most effective healthcare possible for their PS-341 in Treating Patients With Refractory or Progressive 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.
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Home > "P" Clinical Trials Conditions > PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma  PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma
PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma
For Condition: refractory plasma cell neoplasm
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: PS-341 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known if PS-341 is effective in treating patients who have multiple myeloma. PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have refractory or progressive multiple myeloma.
Details: OBJECTIVES: - Determine the time to progressive disease in patients with refractory or progressive multiple myeloma treated with PS-341. - Determine the safety and tolerability of this drug in these patients. - Determine survival of patients treated with this drug. - Determine the rate and duration of response (complete and partial) in patients treated with this drug. - Assess the relationship between selected genetic disease markers and response in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. - Induction therapy: Patients receive PS-341 IV on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses. - Patients receive PS-341 IV on days 1, 8, 15, and 22. Treatment repeats every 5 weeks for up to 3 courses. Patients who experience progressive disease (PD) after at least 2 courses or no change after at least 4 courses may also receive oral dexamethasone on the day of and the day after PS-341 administration. Patients who experience PD after at least 2 courses of this combined therapy go off study. Patients are followed at 30 days, every 6 weeks until disease progression, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of multiple myeloma (MM) and meeting 1 of the following criteria: - Progressive disease during or after treatment with high-dose dexamethasone on MPI Study M34101-039 (FHCRC-1746.00), with no other antineoplastic treatment for MM initiated - Relapsed or progressive disease after receiving at least 4 prior treatment regimens for MM (non-MPI patients) PATIENT CHARACTERISTICS: Age - Adult Performance status - Karnofsky 60-100% (non-MPI patients) Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 500/mm^3 (no growth factor support) - Platelet count at least 20,000/mm^3 (transfusions allowed) - Hemoglobin at least 7.0 g/dL (transfusions allowed) Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN - Hepatitis B surface antigen negative - No known active hepatitis C infection Renal - Calcium less than 14 mg/dL - Creatinine clearance at least 20 mL/min Cardiovascular - Non-MPI patients: - No myocardial infarction within the past 6 months - No New York Heart Association class III or IV heart failure - No uncontrolled angina - No severe uncontrolled ventricular arrhythmias - No acute ischemia or active conduction system abnormalities by EKG - No cardiac amyloidosis - No poorly controlled hypertension Other - All patients: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - Non-MPI patients: - No other serious medical or psychiatric illness that would preclude study - No prior allergic reaction attributable to compounds containing boron or mannitol - No peripheral neuropathy grade 2 or greater - No diabetes mellitus - No active systemic infection requiring treatment - MPI patients: - Recovered from dexamethasone-related toxicity - No other new or worsening existing illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior immunotherapy or antibody therapy (non-MPI patients) - No concurrent thalidomide Chemotherapy - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) (non-MPI patients) Endocrine therapy - See Disease Characteristics - At least 3 weeks since prior corticosteroids (greater than 10 mg/day of prednisone or equivalent) (non-MPI patients) - No other concurrent corticosteroids (e.g., greater than 10 mg/day of prednisone or equivalent) Radiotherapy - Concurrent local short-duration radiotherapy allowed Surgery - At least 4 weeks since prior major surgery (except kyphoplasty) (non-MPI patients) - Concurrent kyphoplasty allowed - Concurrent emergency orthopedic procedures allowed Other - No other concurrent antineoplastic treatment for MM - No other concurrent investigational agents, including commercial agents approved for other indications but investigational for MM - No concurrent clarithromycin - Concurrent bisphosphonates allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamBensinger, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Additional Information:
Study ID Numbers: CDR0000258110; FHCRC-1747.00,NCI-G02-2128,MILLENNIUM-M34101-040
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049478
Other Refractory Plasma Cell Neoplasm Studies:
1. Autologous T Cell Immunotherapy With or Without Fludarabine in Treating Patients With Relapsed or Refractory Multiple Myeloma
2. 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
3. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
4. Tandem Autologous Stem Cell Transplantation With or Without Maintenance Therapy After the Second Transplantation Compared With Autologous Stem Cell Transplantation Followed By Matched Sibling Allogeneic Stem Cell Transplantation in Patients With Stage II or Stage III Multiple Myeloma
5. Antineoplaston Therapy in Treating Patients With Multiple Myeloma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma
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