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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | March 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00003954 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Multiple Myeloma and Plasma Cell Neoplasm | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | up to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00003954 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067153, FHCRC-1383.00, NCI-G99-1538 | ||||
| Study Sponsor ICMJE | Fred Hutchinson Cancer Research Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2002 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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