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Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma Clinical research trials and Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma. Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma clinical trial. Participants frequently get the best healthcare available for their Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma  Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma
Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma
For Condition: stage 1 multiple myeloma,stage 3 multiple myeloma,refractory plasma cell neoplasm,stage 2 multiple myeloma
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Stem cell transplantation may be able to replace immune cells that were destroyed by previous cancer treatment. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may prevent this from happening. PURPOSE: Phase I/II trial to study the effectiveness of donor stem cell transplantation in treating patients who have multiple myeloma that has been previously treated.
Details: OBJECTIVES: - Determine the efficacy of allogeneic hematopoietic stem cell transplantation, in terms of 1-year progression-free survival and overall survival, in patients with previously treated multiple myeloma. - Determine non-relapse mortality at day 100 in patients treated with this regimen. - Determine the incidence of grade II-IV acute graft-versus-host disease (GVHD) and chronic extensive GVHD in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive fludarabine IV on days -5 to -3 and melphalan IV over 15-20 minutes on day -2. Patients undergo total body irradiation and allogeneic hematopoietic stem cell transplantation on day 0. Patients also receive graft-versus-host disease prophylaxis according to the type of donor. - Related donor: Patients receive oral cyclosporine every 12 hours on days -3 to 80 followed by a taper until day 180 and oral mycophenolate mofetil every 12 hours on days 0-27. - Unrelated donor: Patients receive oral cyclosporine every 12 hours on days -3 to 100 followed by a taper until day 177 and oral mycophenolate mofetil every 8 hours on days 0-40 followed by a taper until day 96. Patients are followed at days 28, 56, and 84; at months 6, 12, 18, and 24; and then annually for 5 years. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of multiple myeloma, meeting 1 of the following criteria: - Progressive disease after 1 prior autologous hematopoietic stem cell transplantation (HSCT) (indicated by greater than 25% increase in serum or urine paraprotein levels or appearance of new lytic bone lesions or plasmacytomas) - Unable to collect autologous peripheral blood stem cells due to poor marrow reserve and has progressive disease after at least 4 prior courses of standard chemotherapy (e.g., dexamethasone/doxorubicin/vincristine) - Availability of 1 of the following donors: - HLA genotypically matched identical sibling - HLA phenotypically matched relative - HLA phenotypically matched unrelated donor - Matched for serologically recognized HLA-A or B or C antigens and at least 5/6 HLA-A or B or C alleles - Matched for HLA-DRB1 and DQB1 alleles - No identical twins PATIENT CHARACTERISTICS: Age - 18 to 70 Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGPT and SGOT no greater than 4 times ULN Renal - Creatinine clearance at least 40 mL/min Cardiovascular - LVEF at least 40% - No symptomatic heart failure - No poorly controlled hypertension Pulmonary - DLCO at least 50% - No requirement for continuous supplemental oxygen Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for 12 months after study participation - HIV negative - Cytomegalovirus (CMV)-antigenemia negative - No impaired capacity that would preclude informed consent - No persistent mucositis or gastrointestinal symptoms requiring hyperalimentation and/or IV hydration PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No concurrent thalidomide Chemotherapy - See Disease Characteristics Endocrine therapy - No concurrent steroids for autologous graft-versus-host disease Radiotherapy - No other concurrent radiotherapy Surgery - Not specified Other - Recovered from prior therapy - At least 2 weeks since prior ganciclovir or foscarnet for previous CMV reactivation/infection - No concurrent ganciclovir or foscarnet for previous CMV reactivation/infection - No concurrent IV antibiotics for active infections - No concurrent bisphosphonates during and for 30 days after transplantation
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarcoMielcarek, Study Chair, Fred Hutchinson Cancer Research Center
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Christopher Bredeson 414-456-8325
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Marco Mielcarek 206-667-2827
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Edward Agura 214-820-1800
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Michael Pulsipher 801-224-0421
Additional Information:
Study ID Numbers: CDR0000270417; FHCRC-1743.00
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054353
Other Stage 1 Multiple Myeloma Studies:
1. Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma
2. Combination Chemotherapy Following GM-CSF in Treating Patients With Multiple Myeloma
3. Combination Chemotherapy With or Without Interferon alfa in Treating Patients With Previously Untreated Multiple Myeloma
4. Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
5. CC-5013 in Treating Patients With Advanced Multiple Myeloma
Related Studies:
Other stage 1 multiple myeloma Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma
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