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Home > "M" Clinical Trials Conditions > Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma  Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma
Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma
For Condition: stage 2 multiple myeloma,stage 3 multiple myeloma,stage 1 multiple myeloma,refractory plasma cell neoplasm
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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) --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidMaloney, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Additional Information:
Study ID Numbers: CDR0000067153; FHCRC-1383.00,NCI-G99-1538
Study Start Date: March 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003954
Other Stage 2 Multiple Myeloma Studies:
1. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma
2. Combination Chemotherapy With or Without PSC 833 in Treating Patients With Relapsed or Refractory Multiple Myeloma
3. Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease
4. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
5. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma
Related Studies:
Other stage 2 multiple myeloma Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma
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