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Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma
This study is ongoing, but not recruiting participants.
Study NCT00003954   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
March 1999
 
 
 
Complete list of historical versions of study NCT00003954 on ClinicalTrials.gov Archive Site
 
 
 
Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma
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

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.

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.

Phase I, Phase II
Interventional
Treatment
Multiple Myeloma and Plasma Cell Neoplasm
  • Biological: filgrastim
  • Biological: peripheral blood lymphocyte therapy
  • Drug: cyclophosphamide
  • Drug: cyclosporine
  • Drug: melphalan
  • Drug: mycophenolate mofetil
  • Drug: paclitaxel
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
40
 
 

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

Both
up to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003954
 
CDR0000067153, FHCRC-1383.00, NCI-G99-1538
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: David G. Maloney, MD, PhD Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
February 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP