710
Participants
Start Date
December 31, 2003
Primary Completion Date
June 30, 2012
Study Completion Date
March 31, 2013
One Autologous Transplant
Melphalan will be administered at a dose of 200 mg/m2. Melphalan will be given in one dose infused on Day -2. Melphalan dose is based on ideal body weight (IBW) for patients who weigh 100-120% of their IBW. All patients will receive an autologous graft with a minimum cell dose of 2.0 x 106 CD34+ cells/kg patient weight. Patients will receive \~5 ug/kg/day of Granulocyte-Colony Stimulating Factor (G-CSF) subcutaneously from Day 5 post-transplant until absolute neutrophil count (ANC) \> 500/mm3 for two days.
Non-Myeloablative Allogeneic Transplant
Upon recovery and at least Day 60 post-autograft, patients with an available 6/6 HLA matched sibling will receive an allograft after non-myeloablative conditioning. Day 0 patients will receive Total Body Irradiation (TBI) 2.0 Gy from a linear accelerator ≤ 20 cGy/min, followed by allogeneic peripheral blood stem cell (PBSC) infusion. Commence cyclosporine (CSA) on Day -3 at 5 mg/kg bid PO for a daily dose of 10 mg/kg/day through Day +84 based on actual body weight. Starting on Day 84, patients in partial or complete response with the absence of graph versus host disease (GVHD) will have CSA tapered so the patient will be off CSA by Day 180. Oral administration of Mycophenolate Mofetil will be at a daily dose of 30 mg/kg/day from the evening of Day 0 until Day 27 post-transplant.
Second Autologous Transplant
Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients without an HLA-matched sibling donor will receive a second autograft, also conditioned with melphalan 200 mg/m2.
Thalidomide
Patients will be initiated on a starting dose of 50 mg/day. The dose will be increased weekly by 50 mg as tolerated to achieve a target dose of 200 mg/day. Patients will be treated for 12 months with thalidomide.
Dexamethasone
Patients will receive dexamethasone at a dose of 40 mg per day during Days 1-4 of each month for 12 months. The first dose of dexamethasone to be given the same day the patient starts thalidomide.
Observation
One year of observation post-transplants.
Memorial Sloan-Kettering Cancer Center, New York
University of Pennsylvania Cancer Center, Philadelphia
Virginia Commonwealth University MCV Hospitals, Richmond
Duke University Medical Center, Durham
Emory University, Atlanta
BMT Group of Georgia/Northside Hospital, Atlanta
University of Alabama at Birmingham, Birmingham
Vanderbilt University, Nashville
University Hospitals of Cleveland/Case Western, Cleveland
Jewish Hospital BMT Program, Cincinnati
IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health, Indianapolis
Medical College of Wisconsin, Milwaukee
University of Minnesota, Minneapolis
Loyola University, Maywood
Wichita CCOP, Wichita
University of Nebraska Medical Center, Omaha
University of Oklahoma Medical Center, Oklahoma City
Baylor College of Medicine/The Methodist Hospital, Houston
University of Texas/MD Anderson Cancer Research Center, Houston
Texas Transplant Institute, San Antonio
Colorado Blood Cancer Institute, Denver
Utah BMT/Univ of Utah Med School, Salt Lake City
City of Hope Samaritan, Phoenix
UCSD Medical Center, La Jolla
Stanford Hospital and Clinics, Stanford
City of Hope National Medical Center, Duarte
Scripps Clinic/Green Hospital, La Jolla
University of Florida College of Medicine (Shands), Gainesville
Tufts - New England Medical Center, Boston
DFCI/Brigham & Women's, Boston
University of Michigan Medical Center, Ann Arbor
Hackensack University Medical Center, Hackensack
Oregon Health Sciences University (A), Portland
Fox Chase - Temple University - BMT Program, Philadelphia
Fred Hutchinson Cancer Research Center, Seattle
University of Wisconsin Hospitals & Clinics, Madison
Blood and Marrow Transplant Clinical Trials Network
NETWORK
National Cancer Institute (NCI)
NIH
National Marrow Donor Program
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH