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Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical research trials and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma. Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma clinical trial. Human subjects often get the best healthcare possible for their Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma  Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
For Condition: stage 3 multiple myeloma,refractory plasma cell neoplasm,stage 2 multiple myeloma,stage 1 multiple myeloma
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of autologous peripheral stem cell transplantation followed by donor peripheral stem cell transplantation in treating patients who have multiple myeloma.
Details: OBJECTIVES: - Determine whether autologous peripheral blood stem cell transplantation (PBSCT) followed by non-myeloablative allogeneic PBSCT is associated with no more than 20% treatment-related mortality rates at 6 months in patients with multiple myeloma. - Determine the response rate of patients treated with this regimen. - Determine the percent donor chimerism in patients treated with this regimen. - Determine the rate of graft-vs-host disease in patients treated with this regimen. - Determine the toxic effects of this regimen in these patients. - Determine the disease-free and overall survival of patients treated with this regimen. - Determine whether abnormal cytogenetics at presentation correlate with poor response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until peripheral blood stem cell (PBSC) collection is complete. Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV over 15-30 minutes on day -2. Patients then undergo autologous PBSC transplantation (PBSCT) on day 0. Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover. Approximately 2-4 months after autologous PBSCT, patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 hour on days -4 to -3. Patients undergo allogeneic PBSCT on day 0. Patients receive G-CSF SC beginning on day 7 and continuing until blood counts recover. Patients receive graft-vs-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 followed by a taper on days 91-150 and methotrexate IV on days 1, 3, and 6. After day 120, patients with stable or progressive disease and no evidence of active GVHD may receive donor lymphocyte infusion (DLI) over 2 hours. Patients may receive up to 3 DLIs every 8 weeks. Patients are followed every 3 months for 3 years, every 6 months for 5 years, and then annually for 15 years. PROJECTED ACCRUAL: A maximum of 63 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /64 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of active multiple myeloma that requires treatment - Durie-Salmon stage I, II, and III - No more than 1 progression after initial therapy - Must have HLA-identical sibling donor (6/6) by serologic typing (A, B, DR) - No syngeneic donors - Must also be enrolled on protocol CLB-8461 (Cytogenetic Studies in Acute Leukemia) PATIENT CHARACTERISTICS: Age: - Under 65 Performance status: - NCI CTC 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 500/mm^3 - Platelet count greater than 50,000/mm^3 Hepatic: - Bilirubin less than 2 mg/dL - AST less than 3 times upper limit of normal (ULN) - Alkaline phosphatase less than 3 times ULN Renal: - Creatinine less than 2 mg/dL - Creatinine clearance greater than 40 mL/min Cardiovascular: - LVEF at least 30% by MUGA scan Pulmonary: - DLCO greater than 40% of predicted - No symptomatic pulmonary disease Other: - HIV negative - No uncontrolled diabetes mellitus - No active serious infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy - Prior alkylating-agent therapy allowed if no more than 12 months duration Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - At least 4 weeks since prior surgery Other: - All prior therapy no more than 18 months duration
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KennethZamkoff, , Comprehensive Cancer Center of Wake Forest University
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Saul Yanovich 202-444-7253
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Joseph Antin 617-632-2525
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Craig Moskowitz 212-639-2696
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Randy Brown 314-454-8227
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Mark Green 843-792-4271
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Hurd 336-716-2088
Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Atif Hussein 954-986-6363
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92037-0960
United States
Recruiting Edward Ball 858-657-7053
Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Paul Conkling 757-466-8683
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-982-4963
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Margaret Kessinger 402-559-7511
FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst, North Carolina, 28374
United States
Recruiting Ellen Willard 910-295-9205
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Ronald Takvorian 617-724-1134
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Edison Catalano 856-342-2506
Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Barry Levinson 214-648-4193
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting Sreenivasa Nattam 219-484-8830
Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Steven Krasnow 202-745-8178
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Koen Besien 773-702-6696
NorthEast Oncology Associates *Recruiting*
Concord, North Carolina, 28025
United States
Recruiting James Wall 704-783-1370
Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville, North Carolina, 28805
United States
Recruiting John Lucke 828-299-2540
Northeast Alabama Regional Medical Center *Recruiting*
Anniston, Alabama, 36207
United States
Recruiting Thomas Twele 256-236-2549
New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett, New Hampshire, 03106
United States
Recruiting Douglas Weckstein 603-622-6484
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego, California, 92161
United States
Recruiting Saeeda Kirmani 619-552-8585 ext. 3356
University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Karen Ballen 508-856-1518
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Michael Lill 310-423-2997
Saint Anthony Medical Center *Recruiting*
Rockford, Illinois, 61108
United States
Recruiting Richard Nora 815-227-2273
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Nelson Chao 919-684-3377
Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica, New York, 11432
United States
Recruiting Hans Grunwald 718-883-4118
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263-0001
United States
Recruiting Philip McCarthy 716-845-8707
Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Paul Richards 540-982-0237
University of Puerto Rico School of Medicine Medical Sciences Campus *Recruiting*
San Juan, , 00936-5067
Puerto Rico
Recruiting Enrique Velez-Garcia 787-754-0101 Ext.2020
Cancer Research Institute *Recruiting*
Chapel Hill, North Carolina, 27599-7305
United States
Recruiting Thomas Shea 919-966-7746
Western Pennsylvania Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15224-1791
United States
Recruiting John Lister 412-578-4355
New Hanover Regional Medical Center *Recruiting*
Wilmington, North Carolina, 28402-9025
United States
Recruiting Cyrus Kotwall 910-763-4630
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Roger Gingrich 312-356-3425
Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting Chitha Hulugalle 702-696-3000
Florida Hospital Cancer Institute *Recruiting*
Orlando, Florida, 32804
United States
Recruiting Jane Crofton 407-303-2090
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Broward General Medical Center *Recruiting*
Ft. Lauderdale, Florida, 33316
United States
Recruiting Luis Barreras 954-771-0692
Cape Fear Valley Health System *Recruiting*
Fayetteville, North Carolina, 28302-2000
United States
Recruiting Kamal Bakri 910-609-6910
Martha Jefferson Hospital *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Stefan Gorsch 434-982-8410
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Ruthee-Lu Bayer 516-562-8973
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Keith Shulman 773-564-5022
Baptist Hospital East - Louisville *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting Daniel Scullin 502-897-1166
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Sherif Farag 614-293-7527
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Steven Fruchtman 212-241-6021
Massey Cancer Center at Virginia Commonwealth University *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John McCarty 804-828-4360
St. Mary's Medical Center *Recruiting*
Huntington, West Virginia, 25701
United States
Recruiting Gerrit Kimmey 304-528-4645
West Suburban Center for Cancer Care *Recruiting*
River Forest, Illinois, 60305
United States
Recruiting John Showel 708-763-2700
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Charles Linker 415-353-9510
Elmhurst Hospital Center *Recruiting*
Elmhurst, New York, 11373
United States
Recruiting Vladimir Benisovich 718-334-3723
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Bruce Peterson 612-624-5631
Palm Beach Cancer Institute *Recruiting*
West Palm Beach, Florida, 33401
United States
Recruiting Robert Jacobson 561-366-4150
Lenoir Memorial Hospital Cancer Center *Recruiting*
Kinston, North Carolina, 28503-1678
United States
Recruiting Peter Watson 919-559-2200 Ext. 201
Additional Information:
Study ID Numbers: CDR0000069109; CALGB-100001
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028600
Other Stage 3 Multiple Myeloma Studies:
1. Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
2. Chemotherapy and Peripheral Stem Cell Transplantation Followed By Immunotherapy in Treating Patients With Multiple Myeloma
3. High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis
4. R115777 in Treating Patients With Relapsed or Refractory Multiple Myeloma
5. Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma
Related Studies:
Other stage 3 multiple myeloma Clinical Trials
Other Clinical Trials
Other San Juan Clinical Trials
Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
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