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Protocol No. 2004LS001 Principal Investigator McClune, Brian
Phase Phase II
Age Group Adult Scope Local
Secondary Protocol No. MT2003-13
Title MT2003-13 Autologous Transplantation for Multiple Myeloma
Objective This clinical trial is studying how well giving cyclophosphamide and melphalan followed by an autologous stem cell transplant together with dexamethasone and thalidomide works in treating patients with previously treated multiple myeloma.
Treatment Patients receive high-dose cyclophosphamide IV, filgrastim (G-CSF) and undergo stem cell collection. Patients with an insufficient number of stem cells are removed from study. Beginning 2-4 weeks later, patients deemed suitable by the principal investigator receive high-dose melphalan IV and undergo autologous peripheral blood stem cell transplantation. Patients also receive G-CSF (growth hormone) until blood counts recover. Patients may receive radiotherapy. After blood counts recovery, patients receive maintenance therapy comprising dexamethasone and thalidomide. Treatment with dexamethasone and thalidomide may continue for up to 1 year in the absence of unacceptable toxicity.
Description Drugs used in chemotherapy, such as cyclophosphamide, melphalan, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. A stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving chemotherapy with a stem cell transplant, using stem cells from the patient, may allow more chemotherapy to be given so more cancer cells are killed. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving maintenance therapy, using dexamethasone and thalidomide, after an autologous stem cell transplant may kill any cancer cells that remain.
Key Eligibility Diagnosis of multiple myeloma (previously treated disease).
Applicable Disease Sites Hematologic Malignancies
Multiple Myeloma
Therapies Involved Blood and Marrow Transplant
Drugs Involved CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
DEXAMETHASONE (DECADRON)
FILGRASTIM (G-CSF, NEUPOGEN)
MELPHALAN (ALKERAN)
THALIDOMIDE
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Patient must be no more than 70-years-old. HIV and hepatitis status must be known. Women who are pregnant or nursing are not eligible. Males and females of reproductive potential must agree to use effective contraception. A signed informed consent and HIPAA authorized are required; assent form for minors is also required.
Treatment Type Treatment
Contact Timothy Krepski Phone:612-273-2800
Email:tkrepsk1@fairview.org