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Sponsored by: |
Medical College of Wisconsin |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003163 |
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.
Condition | Intervention | Phase |
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Lymphoma Multiple Myeloma and Plasma Cell Neoplasm |
Biological: filgrastim Biological: sargramostim Drug: cyclophosphamide Drug: melphalan Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Myeloblative Therapy With Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and B-Cell Malignancies |
Estimated Enrollment: | 10 |
Study Start Date: | September 1997 |
OBJECTIVES:
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
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed multiple myeloma or other B-cell malignancy including non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia, or amyloidosis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Study Chair: | David H. Vesole, MD, PhD | Medical College of Wisconsin |
Study ID Numbers: | CDR0000065959, MCW-96110, MCW-HRRC-29196, NCI-V97-1368 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003163 History of Changes |
Health Authority: | United States: Federal Government |
refractory multiple myeloma Waldenstrom macroglobulinemia stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV grade 1 follicular lymphoma |
stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
Melphalan Immunologic Factors Blood Protein Disorders Lymphoma, Mantle-Cell Lymphoma, Follicular Mantle Cell Lymphoma Lymphoma, B-Cell, Marginal Zone Paraproteinemias Cyclophosphamide Hemostatic Disorders Lymphoblastic Lymphoma Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell |
Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell Leukemia, B-cell, Chronic Alkylating Agents Lymphoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Immunosuppressive Agents Recurrence Multiple Myeloma |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Cyclophosphamide Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Cardiovascular Diseases Alkylating Agents Lymphoma Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Vascular Diseases Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Lymphatic Diseases Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents Neoplasms, Plasma Cell |