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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: | NCT00003954 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Total-body irradiation and drug therapy may be used to suppress the immune system and reduce the chance of developing graft-versus-host disease following transplantation.
PURPOSE: Phase I/II trial to study the effectiveness of high-dose melphalan and autologous peripheral stem cell transplantation followed by immunosuppressive therapy and allogeneic peripheral stem cell transplantation in treating patients who have multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: cyclophosphamide Drug: cyclosporine Drug: filgrastim Drug: melphalan Drug: mycophenolate mofetil Drug: paclitaxel Procedure: peripheral blood lymphocyte therapy Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Allogeneic Stem Cell Transplantation for Multiple Myeloma: A Two Step Approach to Reduce Toxicity Involving High-Dose Melphalan and Autologous Stem Cell Transplant Followed by PBSC Allografting After Low Dose TBI |
Estimated Enrollment: | 40 |
Study Start Date: | March 1999 |
OBJECTIVES: I. Determine engraftment of HLA identical peripheral blood stem cell allografts given after conditioning with total body irradiation and postgrafting immunosuppression with cyclosporine/mycophenolate mofetil in patients with multiple myeloma initially cytoreduced with high dose melphalan. II. Determine disease free survival of these patients at day 100 post allografting. III. Determine the efficacy of this regimen in terms of long term progression free survival of these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1, paclitaxel IV over 4 hours on day 2, and filgrastim (G-CSF) subcutaneously (SQ) beginning on day 3 and continuing until the end of leukapheresis. Autologous peripheral blood stem cells (PBSC) are collected over 3-4 days and selected for CD34+ cells. Patients receive melphalan IV on day -2 (which is at least 31 days after paclitaxel), then autologous CD34+ PBSC are reinfused on day 0. G-CSF SQ or IV is administered beginning on day 0 and continuing until blood counts recover. About 40-120 days after autografting, patients receive cyclosporine IV twice a day on days -1 and 0, then orally on days 1-56 and oral mycophenolate mofetil twice a day on days 0-27. Patients undergo total body irradiation on day 0, followed by infusion of unmodified donor PBSC. At days 28 and 56, patients are evaluated for lymphoid and myeloid chimerism. Patients with stable mixed chimerism on day 56 without graft versus host disease receive nonmobilized donor lymphocyte infusion (DLI) over 30 minutes on day 65. Patients may receive up to 4 DLI's. Patients are followed weekly until day 90 after the last T-cell infusion, then at 4 and 6 months, then every 6 months for 1.5 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued within 4 years.
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Cytologically diagnosed multiple myeloma (MM) Stage II or III at diagnosis OR Progressive after initial diagnosis of stage I disease and received chemotherapy and/or radiotherapy Must have received at least 4 courses of conventional dose chemotherapy for MM HLA genotypically identical sibling available (not identical twin)
PATIENT CHARACTERISTICS: Age: 65 and under Performance status: Karnofsky 60-100% (unless less than 60% due solely to MM) Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN Renal: Creatinine clearance at least 40 mL/min Cardiovascular: LVEF at least 40% No poorly controlled hypertension Pulmonary: DLCO at least 50% corrected No continuous supplemental oxygen Other: Not pregnant Fertile patients must use effective contraception during and for 12 months after study HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior autograft Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No concurrent radiotherapy with melphalan administration Surgery: Not specified
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109 |
Study Chair: | David G. Maloney, MD, PhD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000067153, FHCRC-1383.00, NCI-G99-1538 |
Study First Received: | November 1, 1999 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00003954 |
Health Authority: | United States: Federal Government |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Melphalan Immunoproliferative Disorders Cyclosporine Clotrimazole Blood Protein Disorders Hematologic Diseases Miconazole Blood Coagulation Disorders Tioconazole Vascular Diseases Paraproteinemias |
Cyclophosphamide Hemostatic Disorders Cyclosporins Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Paclitaxel Mycophenolate mofetil Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Infective Agents Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Antifungal Agents Therapeutic Uses Tubulin Modulators Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Dermatologic Agents Alkylating Agents |