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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00054353 |
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: This phase I/II trial is studying donor stem cell transplantation to see how well it works in treating patients with multiple myeloma that has been previously treated.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: cyclosporine Drug: fludarabine phosphate Drug: melphalan Drug: mycophenolate mofetil Drug: therapeutic allogeneic lymphocytes Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Reduced-Intensity Allogeneic HSC Transplantation From HLA-Matched Related and Unrelated Donors for Patients With Multiple Myeloma |
Estimated Enrollment: | 30 |
Study Start Date: | October 2002 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV over 30 minutes 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.
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma, meeting 1 of the following criteria:
Availability of 1 of the following donors:
HLA phenotypically matched unrelated donor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109-1023 | |
Italy | |
Universita di Torino | |
Turin, Italy, 10126 |
Study Chair: | Marco B. Mielcarek, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Marco B. Mielcarek ) |
Study ID Numbers: | CDR0000270417, FHCRC-1743.00 |
Study First Received: | February 5, 2003 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00054353 |
Health Authority: | United States: Federal Government |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
Melphalan Immunoproliferative Disorders Cyclosporine Clotrimazole Blood Protein Disorders Hematologic Diseases Miconazole Blood Coagulation Disorders Tioconazole Vascular Diseases Paraproteinemias |
Fludarabine monophosphate Hemostatic Disorders Cyclosporins Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Mycophenolate mofetil Fludarabine Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Antifungal Agents Therapeutic Uses Cardiovascular Diseases Antirheumatic Agents Dermatologic Agents |