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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.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003954
  Purpose

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
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

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Cancer    Multiple Myeloma   

Drug Information available for:   Cyclophosphamide    Filgrastim    Melphalan    Paclitaxel    Cyclosporin    Cyclosporine    Mycophenolate Mofetil    Mycophenolate mofetil hydrochloride    Melphalan hydrochloride    Sarcolysin   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   40
Study Start Date:   March 1999

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.

  Eligibility
Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003954

Locations
United States, Washington
Fred Hutchinson Cancer Research Center    
      Seattle, Washington, United States, 98109

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)

Investigators
Study Chair:     David G. Maloney, MD, PhD     Fred Hutchinson Cancer Research Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067153, FHCRC-1383.00, NCI-G99-1538
First Received:   November 1, 1999
Last Updated:   November 16, 2008
ClinicalTrials.gov Identifier:   NCT00003954
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma  
stage I multiple myeloma  
stage II multiple myeloma  
stage III multiple myeloma  

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 30, 2008




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