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Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical research trials and Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma. Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma clinical trial. Human subjects often get the best healthcare available for their Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma  Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
For Condition: stage 3 multiple myeloma,refractory plasma cell neoplasm,stage 1 multiple myeloma,stage 2 multiple myeloma
Status: No longer recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have relapsed or refractory multiple myeloma.
Details: OBJECTIVES: - Determine the response rate in patients with relapsed or refractory multiple myeloma treated with flavopiridol. - Determine the disease-free survival and overall survival of patients treated with this drug. - Correlate disease response with t(11;14)(q13;q32) rearrangement, p16 methylation status, and BCRP expression in patients treated with this drug. - Correlate disease response and drug treatment with cell cycle status and effects on apoptosis and apoptosis regulatory proteins in these patients. OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour on days 1-3. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients achieving at least a partial response may continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: A maximum of 35 patients will be accrued for this study within approximately 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of relapsed or refractory multiple myeloma (MM) requiring treatment - Durie-Salmon stage I or greater at diagnosis - Patients with non-secretory or oligo-secretory MM (defined as maximum urinary M-spike less than 200 mg/24 hours and a maximum serum M-spike less than 0.5 g/dL during entire disease course) must have at least 30% bone marrow plasma cells - Patients with secretory MM must have measurable disease defined as serum monoclonal protein of at least 1 g/dL or urinary M-spike of at least 200 mg/24 hours - Must have received at least 1, but no more than 5 prior therapy regimens - Patients who have had 4 or 5 regimens are allowed provided corticosteroids and/or thalidomide are part of the regimens - No more than 5 prior chemotherapy regimens (as long as 2 contained dexamethasone or thalidomide) - Prior autologous peripheral blood stem cell transplantation is considered 1 prior regimen PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - ECOG 0-3 if secondary to neuropathy or acute bone event (e.g., vertebral compression or rib fracture) Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 750/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - AST no greater than 2.5 times ULN Renal - Creatinine no greater than 3 mg/dL Cardiovascular - No myocardial infarction within the past 6 months Other - Peripheral neuropathy secondary to prior drug therapy or myeloma-associated neuropathy allowed - No other uncontrolled serious medical condition - No uncontrolled infection - No other active malignancy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior allogeneic stem cell transplantation - At least 10 days since prior thalidomide - No concurrent biologic therapy Chemotherapy - See Disease Characteristics - At least 2 weeks since prior myelosuppressive chemotherapy - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - No concurrent corticosteroids (including as antiemetics) except chronic corticosteroids for disorders other than myeloma (e.g., rheumatoid arthritis or adrenal insufficiency) - Maximum dose allowed for prednisone is no more than 10 mg/day or hydrocortisone no more than 40 mg/day Radiotherapy - Not specified Surgery - Not specified Other - At least 10 days since prior bortezomib or tipifarnib - Concurrent bisphosphonates allowed if on stable dose before study entry
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AngelaDispenzieri, Study Chair, Mayo Clinic - Rochester
Howard University College of Medicine
Washington D.C., District of Columbia, 20059
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-5256
United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Additional Information:
Study ID Numbers: CDR0000257567; MAYO-MC018B,NCI-5758
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047203
Other Stage 3 Multiple Myeloma Studies:
1. Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma
2. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma
3. Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma
4. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
5. Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Related Studies:
Other stage 3 multiple myeloma Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
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