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Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure 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 Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure Clinical research trials and Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure 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 Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure. Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure 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 Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure clinical trial. Human subjects often get the best healthcare possible for their Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure 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 > "C" Clinical Trials Conditions > Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure
Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure
For Condition: Multiple Myeloma,Kidney Failure, Chronic
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Immune Tolerance Network
Synopsis: The purpose of this study is to determine whether a combined bone marrow and kidney transplant will be effective in treating stage II or greater multiple myeloma and associated kidney failure. This study will determine whether transplant rejection and the need for immunosuppressive drugs are decreased with this combined transplant approach.
Details: In very limited human testing, a combined kidney and bone marrow transplant appears to be safe and effective in treating multiple myeloma and associated kidney failure. This study will evaluate this approach in 10 patients with kidney failure due to or in association with stage II or greater multiple myeloma. Treatment prior to transplant will include cyclophosphamide, ATGAM (a lymphocyte-specific immunosuppressant), local radiation to the thymus, and cyclosporine (an immunosuppressive drug). An infusion of donor bone marrow and a kidney graft from a closely matched, related donor will be transplanted simultaneously. An additional infusion of donor white blood cells may be administered between day 45 and 74 after transplant in an effort to eliminate any remaining cancer cells. Patients will remain on cyclosporine for a defined period of time. The cyclosporine doses will be slowly decreased and stopped if graft rejection and graft-versus-host disease do not occur. Each participant will be involved in the study for 3 years; this includes the intervention phase (time from initial screening at approximately 7 days before transplant through 100 days after the transplant) and continued follow-up visits for at least 2 years following the transplant.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - End-stage renal disease (ESRD) due to or in association with stage II or greater multiple myeloma - Participants in whom the development of ESRD is not due to the underlying myeloma will be included if they have evidence of active myeloma despite past treatment with standard therapies (e.g., prednisone, melphalan, or high-dose radiation therapy with autologous stem cell transplantation) - On dialysis or have a creatinine clearance > 20 ml/min - HLA-matched or one of six HLA antigen-mismatched related donor Exclusion Criteria - Compromised pulmonary, cardiac, or liver function - Active infection
Total Enrollment: 10
Location and Contact Information:
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114-2696
United States
Recruiting Thomas Spitzer 617-724-1126
Emory Transplant Center *No longer recruiting*
Atlanta, Georgia, 30322
United States
No longer recruiting
Mount Sinai Medical Center *No longer recruiting*
New York City, New York, 10029
United States
No longer recruiting
Additional Information:
Study ID Numbers: ITN008ST; DAIT NKDO1,NKDO1
Study Start Date: June 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062621
Other Multiple Myeloma Studies:
1. Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation
2. Efficacy Study of 6474 to treat Multiple Myeloma Cancer
3. Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
4. Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
5. Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Georgia Clinical Trials
Other Atlanta Clinical Trials
Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure
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