Autologous Transplantation for Multiple Myeloma
Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check
the subject's general health. Subjects will have the following tests and evaluations to
find out if they can participate:--Medical history and physical examination, including
height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest
x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test
(PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will
have a serum pregnancy test performed. After eligible patients have been completely staged
and exercised consent, they may undergo one cycle of chemotherapy (cyclophosphamide and
Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for
collection. All patients will receive high-dose melphalan followed by an autologous stem
cell transplant (SCT). Blood tests will be performed frequently to evaluate the subject's
response to treatment and possible side effects of treatment. If necessary, platelet and
red cell transfusions will be given to maintain adequate levels and antibiotics will be
given to treat or prevent infection. Subjects may also require intravenous nutritional
support and pain medications during or after transplantation. The study coordinators will
collect health information over three years. They will collect information every week for
100 days, then at 6 months, 1 year, 2 years, and 3 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of Percentage of Patients Achieving a Complete Response
Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: Normal free light chain ratio Absence of clonal cells in bone marrow Complete Response (CR): Absence of the original monoclonal paraprotein <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy No increase in size or number of lytic bone lesions Disappearance of soft tissue plasmacytomas.
100 Days, 6 Months, 1 Year Post Treatment
No
Brian McClune, DO
Principal Investigator
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
2004LS001
NCT00177047
January 2004
December 2015
Name | Location |
---|---|
Masonic Cancer Center, University of Minnesota | Minneapolis, Minnesota 55455 |