Spots Global Cancer Trial Database for Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)
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Trial Identification
Brief Title: Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)
Official Title: A Trial of Single Autologous Transplant With or Without Consolidation Therapy Versus Tandem Autologous Transplant With Lenalidomide Maintenance for Patients With Multiple Myeloma (BMT CTN 0702)
Study ID: NCT01109004
Conditions
Study Description
Brief Summary: The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy or single autologous transplant plus maintenance therapy as part of upfront treatment of multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in all arms.
Detailed Description: The primary objective of the randomized trial is to compare three-year progression-free survival (PFS) between the three treatment arms as a pairwise comparison. Mobilization therapy will not be specified for the study. Randomization to three treatment arms will be done prior to the first transplants. All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive either a second autologous PBSC transplant with the same conditioning regimen as the first transplant or consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40 mg on Days 1, 8 and 15, and bortezomib 1.3mg/m\^2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles) or maintenance with lenalidomide (15 mg daily). All patients will also receive maintenance lenalidomide which will start after the second transplant, after the first autologous transplant or after consolidation therapy depending on the treatment arm. Maintenance therapy with lenalidomide will start at 10 mg daily for three months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Cancer Center, Tucson, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
UCSD Medical Center, La Jolla, California, United States
University of California, San Francisco, San Francisco, California, United States
Stanford Hospital and Clinics, Stanford, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Christiana Care Health System, Newark, Delaware, United States
University of Florida College of Medicine, Gainesville, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Blood and Marrow Transplant Program at Northside Hospital, Atlanta, Georgia, United States
Georgia Health Sciences University, Augusta, Georgia, United States
St. Lukes Mountain States Tumor Institute, Boise, Idaho, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Illinois, Chicago, Illinois, United States
Advocate Lutheran General Hospital, Park Ridge, Illinois, United States
University of Kansas Hospital, Kansas City, Kansas, United States
Wichita CCOP, Wichita, Kansas, United States
University of Kentucky, Lexington, Kentucky, United States
Louisiana State University Health Sciences Center, Shreveport, Louisiana, United States
DFCI, Brigham and Womens Hospital, Boston, Massachusetts, United States
DFCI, Massachusetts General Hospital, Boston, Massachusetts, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
Karmanos Cancer Institute/BMT, Detroit, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Washington University, Barnes Jewish Hospital, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Center, Buffalo, New York, United States
North Shore University Hospital, Lake Success, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
University of North Carolina Hospital at Chapel Hill, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Jewish Hospital BMT Program, Cincinnati, Ohio, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
Ohio State/Arthur G. James Cancer Hospital, Columbus, Ohio, United States
University of Oklahoma Medical Center, Oklahoma City, Oklahoma, United States
Oregon Health & Science University, Portland, Oregon, United States
Penn State College of Medicine, The Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Sarah Cannon Blood & Marrow Transplant Program, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Baylor College of Medicine/The Methodist Hospital, Houston, Texas, United States
University of Texas, MD Anderson CRC, Houston, Texas, United States
Texas Transplant Institute, San Antonio, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
West Virginia University Hospital, Morgantown, West Virginia, United States
University of Wisconsin Hospital & Clinics, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Mary Horowitz, MD
Affiliation: Center for International Blood and Marrow Transplant Research
Role: STUDY_DIRECTOR
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