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Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers 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 or Other B-cell Cancers Clinical research trials and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers health trials occur in many 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 effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers. Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers clinical trial. Test subjects typically receive the most expert healthcare available for their Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid 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 or Other B-cell Cancers  Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers
Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers
For Condition: Lymphoma,Multiple Myeloma
Status: No longer recruiting
Sponsor(s): Medical College of Wisconsin ,
Synopsis: RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have multiple myeloma or other B-cell cancers.
Details: OBJECTIVES: I. Determine the safety and efficacy of myeloablative therapy with autologous hematopoietic stem cell transplantation in patients with multiple myeloma and other B-cell malignancies. II. Determine the efficacy and pretransplantation prognostic factors associated with myeloablative therapy in these patients. III. Determine engraftment kinetics of granulocytes and platelets, as well as blood product transfusion requirements following hematopoietic stem cell transplantation. PROTOCOL OUTLINE: Patients must have hematopoietic stem cell procurement completed prior to myeloablative therapy. Patients receive high dose chemotherapy with autologous hematopoietic stem cell transplantation and supportive care. Melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion. Peripheral blood stem cells and/or bone marrow is reinfused on day 0. Filgrastim (G-CSF) or sargramostim (GM-CSF) is administered beginning on day 1 posttransplantation and continuing until blood counts recover. Patients who are not candidates for tandem transplant may receive melphalan plus total body irradiation (TBI). Melphalan is administered IV on day -4. Total body irradiation is administered three times a day on days -3 and -2 and twice on day -1. At least 4 hours must elapse between each treatment. Hematopoietic stem cells are reinfused on day -1 upon completion of TBI or on day 0. If patient is ineligible for melphalan plus TBI, the alternative single high dose regimen of melphalan plus cyclophosphamide is administered. Melphalan, for these patients, is given in two equal doses on day -4 followed by two consecutive days of cyclophosphamide on days -3 and -2. Hematopoietic stem cells are reinfused on day 0. A second transplant may be considered, preferably between 3 and 6 months after the first transplant. The preferred regimen for the second transplant is melphalan alone or melphalan plus TBI as described above. The alternative regimens for the second dose therapy are melphalan alone or melphalan plus cyclophosphamide. For patients receiving melphalan alone, melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion. Hematopoietic stem cells are reinfused on day 0 for both alternative regimens. Patients are followed for response from treatment for a minimum of 4 weeks and then periodically for survival. PROJECTED ACCRUAL: A minimum of 10 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed multiple myeloma or other B-cell malignancy including non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia, or amyloidosis - Non-Hodgkin's lymphoma with T-cell immunophenotypes included --Prior/Concurrent Therapy-- Biologic therapy: At least 2 weeks since prior biologic therapy Chemotherapy: At least 2 weeks since other prior chemotherapy and recovered Endocrine therapy: - At least 2 weeks since prior endocrine therapy - Concurrent steroids allowed Radiotherapy: Not specified Surgery: Not specified --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: - WBC at least 2,000/mm3 (unless due to disease) - Platelet count at least 100,000/mm3 (unless due to disease) Hepatic: Not specified Renal: Not specified Cardiovascular: LVEF at least 40% Pulmonary: DLCO or FVC and FEV1 at least 50% of predicted unless due to restriction from volume loss secondary to disease Other: - HIV negative - No overt infection or unexplained fever requiring broad spectrum antibiotics - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidVesole, Study Chair, Medical College of Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Additional Information:
Study ID Numbers: CDR0000065959; MCW-96110,NCI-V97-1368,MCW-HRRC-29196
Study Start Date: September 1997
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003163
Other Multiple Myeloma Studies:
1. An Open Protocol for the Compassionate Use of Thalidomide for Patients with Advanced or Refractory Malignancies
2. Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
3. Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
4. Study of the Safety and Efficacy of an Investigational Drug in Adult Patients with Multiple Myeloma
5. Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Wisconsin Clinical Trials
Other Milwaukee Clinical Trials
Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers
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