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Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With 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 Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical research trials and Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With 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 Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With 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 Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma clinical trial. Participants frequently get the best healthcare available for their Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With 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 > "C" Clinical Trials Conditions > Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma  Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
For Condition: stage 1 multiple myeloma,refractory plasma cell neoplasm,Graft Versus Host Disease,stage 2 multiple myeloma,stage 3 multiple myeloma
Status: Suspended
Sponsor(s): Eastern Cooperative Oncology Group , 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. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells are rejected by the body's tissues. Peripheral stem cell transplantation with the person's own stem cells followed by donor peripheral stem cell transplantation may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus autologous peripheral stem cell transplantation followed by donor peripheral stem cell transplantation in treating patients who have multiple myeloma.
Details: OBJECTIVES: - Determine the incidence of early mortality in patients with multiple myeloma treated with melphalan and autologous peripheral blood stem cell (PBSC) transplantation followed by fludarabine, cyclophosphamide, and allogeneic PBSC transplantation. - Determine the incidence of early allogeneic graft failure (before day 100 after allogeneic PBSC transplantation) and the incidence of severe acute graft-versus-host disease (GVHD) in patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Determine the overall and disease-free survival of patients treated with this regimen. - Determine the relationship between changes in the T-cell population and clinical outcome such as survival in patients treated with this regimen. - Determine the relationship between changes in the T-cell population and the incidence of GVHD, use of immunosuppressive agents, and effects of fludarabine in patients treated with this regimen. - Determine the degree of chimerism after allogeneic PBSC transplantation and the time course over which it is established in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive melphalan IV over 15 minutes on day -1. Autologous peripheral blood stem cells (PBSC) are reinfused on day 0. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) or IV over at least 30 minutes daily beginning on day 1 and continuing until blood counts recover. Beginning 100-182 days after autologous PBSC transplantation, patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1-2 hours on days -3 and -2. Allogeneic PBSC are infused on day 0. Patients may receive a second allogeneic PBSC infusion on day 1. Patients also receive sargramostim (GM-CSF) SC or IV over at least 30 minutes daily beginning on day 1 and continuing until blood counts recover. Cyclosporine is administered IV or orally twice daily as graft-versus-host disease (GVHD) prophylaxis, beginning on day -1 and continuing until day 60, followed by a taper in the absence of GVHD. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total 19-35 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 - Bone marrow plasmacytosis with at least 10% plasma cells OR - Sheets of plasma cells OR - Biopsy-proven plasmacytoma - At least 1 of the following: - Presence of myeloma (M)-protein in the serum - Presence of M-protein in the urine - Radiographic evidence of osteolytic lesions - Generalized osteoporosis allowed if at least 20% plasma cells in bone marrow - No non-secretory myeloma - Prior M-protein in serum or urine but now in complete remission allowed - Must be receiving conventional dose chemotherapy as initial therapy or as salvage therapy - Must have HLA-A, B, and DR genotypically identical sibling donor PATIENT CHARACTERISTICS: Age: - 18 to 70 Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - AST no greater than 3 times upper limit of normal - Bilirubin less than 2.0 mg/dL Renal: - Not specified Cardiovascular: - LVEF greater than 40% at rest if symptomatic cardiac disease Pulmonary: - DLCO greater than 50% predicted (corrected for hemoglobin) if symptomatic pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior autologous or allogeneic peripheral blood stem cell or bone marrow transplantation Chemotherapy: - See Disease Characteristics - At least 28 days since prior chemotherapy (including primary chemotherapy for hematopoietic stem cell collection) - No other concurrent cytotoxic chemotherapy between autologous and allogeneic transplantation Endocrine therapy: - Prior dexamethasone or other corticosteroids allowed - Concurrent corticosteroids between autologous and allogeneic transplantation allowed Radiotherapy: - Concurrent radiotherapy between autologous and allogeneic transplantation allowed Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NealFlomenberg, Study Chair, Kimmel Cancer Center (KCC)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, 10466
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3596
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705-2286
United States
Additional Information:
Study ID Numbers: CDR0000068551; E-4A98
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014508
Other Refractory Plasma Cell Neoplasm Studies:
1. Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
2. Phase I/II Study of Nonmyeloablative Allogeneic Bone Marrow Transplantation in Patients With High Risk Hemoglobinopathy
3. Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract
4. Combination Chemotherapy and Antithymocyte Globulin in Reducing Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplantation For Myelodysplastic Syndrome or Myeloproliferative Disorder
5. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
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