60
Participants
Start Date
September 30, 2012
Primary Completion Date
April 11, 2017
Study Completion Date
April 11, 2017
Autologous peripheral blood stem cell transplant
Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.
Lenalidomide
Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
Dexamethasone
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
Stem cell collection
Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is \>2500 x 109 cells/liter; platelet count is \>20 x 103/mm3.
Melphalan
Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.
G-CSF
Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.
Cyclophosphamide
Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
Mesna
Mesna will be provided with the cyclophosphamide.
Columbia University, New York
Columbia University
OTHER