SWOG 0115: A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m2) and Autologous Peripheral Blood Stem Cell Supported Transplantation (SCT) for High Risk Patients with Multiple Myeloma and/or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study).
Sponsor:
Southwest Oncology Group
PI:
Laura Hutchins, M.D.
Phase:
II
Purpose:
The purpose of this study is to find out whether using a high dose of melphalan in preparation for transplantation will aid in your disease. We also want to find out whether using the drugs thalidomide and dexamethasone together after transplant will keep the disease from coming back
Eligibility:
An estimated 5 patients, ages 18 and older, will be entered onto this study at this institution. Overall accrual is anticipated to be 100 patients.
Treatment:
If you agree to take part in this study, the drug dexamethasone will be given to you by mouth on Days 1-4, 9-12 and 17-20. The treatment with dexamethasone will be repeated every 5 weeks for 2 cycles. If your disease starts to get worse during this time, then only 1 cycle (35 days) of dexamethasone will be given and you will move on to the next treatment step. At the same time you will also be given thalidomide by mouth every day on Days 1-70. Within about 4 to 5 weeks after your last dose of dexamethasone and thalidomide, your stem cells will be mobilized with the drugs cyclophosphamide and G-CSF. You will receicyclophosphamide into your vein on Day 1 over about two to three hours. Mesna will be given to you with the cyclophosphamide to lessen the chance of harming your bladder.
