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Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma Clinical research trials and Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma medical trials happen in hundreds of localities throughout the U.S.A.. 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 does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma clinical trial. Participants frequently obtain the most expert healthcare available for their Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma  Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma
Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma
For Condition: stage 1 multiple myeloma,stage 3 multiple myeloma,refractory plasma cell neoplasm,stage 2 multiple myeloma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Southwest Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide for multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without thalidomide in treating patients who have refractory multiple myeloma.
Details: OBJECTIVES: I. Compare the overall and progression-free survival and remission rates in patients with refractory multiple myeloma treated with dexamethasone, cyclophosphamide, etoposide, cisplatin, and filgrastim (G-CSF) with or without thalidomide. II. Compare the qualitative and quantitative toxic effects of these regimens in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior transplantation (yes vs no), prior treatment failure (resistant vs relapsing), prior treatment regimens (1-2 vs 3-4), and prior thalidomide (no vs some). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral dexamethasone daily and cyclophosphamide, etoposide, and cisplatin (DCEP) IV continuously on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover. Treatment continues every 3-4 weeks for 3 courses. Patients achieving stable disease or better proceed to maintenance DCEP chemotherapy administered every 8 weeks for 3 additional courses. Arm II: Patients receive DCEP chemotherapy as in arm I plus oral thalidomide daily. Thalidomide continues with maintenance chemotherapy and then continues after chemotherapy is completed until disease progression. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years. PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed stage I, II, or III multiple myeloma with protein criteria present; Quantifiable M-components of IgG, IgA, IgD, IgE AND/OR Urinary kappa or lambda light chain excretion; No IgM peaks; Quantifiable monoclonal proteins - Received at least 1, but no more than 4 prior treatment regimens, including the following: Chemotherapy; Bone marrow transplantation; Biologic therapy; Radiotherapy; Interferon therapy or steroid pulsing given as maintenance therapy after transplantation or chemotherapy is not considered a separate treatment regimen - Progressive disease --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; Prior thalidomide allowed if received no more than 3 months of therapy; Recovered from prior biologic therapy - Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy and recovered; No other concurrent chemotherapy - Endocrine therapy: See Disease Characteristics; No concurrent hormonal therapy - Radiotherapy: See Disease Characteristics; At least 3 weeks since prior extensive or limited radiotherapy and recovered; No concurrent radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Zubrod 0-2 (3-4 allowed if due solely to bone pain) - Life expectancy: Not specified - Hematopoietic: Absolute granulocyte count at least 1,000/mm3; Platelet count at least 50,000/mm3 (at least 50% plasma cells in bone marrow) - Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN); SGOT or SGPT no greater than 2.5 times ULN - Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use 2 methods of effective contraception for 4 weeks before, during, and 4 weeks after study; No other prior or concurrent malignancies within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer in complete remission; No preexisting peripheral neuropathy grade 2 or greater
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MohamadHussein, Study Chair, Southwest Oncology Group
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0209
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, 85012
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Hematology Oncology Associates
Atlantis, Florida, 33462
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Texas Tech University Health Science Center
Lubbock, Texas, 79423
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-0250
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Oregon Cancer Center
Portland, Oregon, 97201-3098
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Additional Information:
Study ID Numbers: CDR0000067848; SWOG-S9922
Study Start Date: April 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005834
Other Stage 2 Multiple Myeloma Studies:
1. PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma
2. Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
3. Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma
4. Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma
5. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Related Studies:
Other stage 2 multiple myeloma Clinical Trials
Other New Mexico Clinical Trials
Other Albuquerque Clinical Trials
Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma
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