Spots Global Cancer Trial Database for Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)
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Trial Identification
Brief Title: Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)
Official Title: A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy vs Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-myeloablative Allogeneic Stem Cell Transplant for Patients With Multiple Myeloma (BMT CTN #0102)
Study ID: NCT00075829
Conditions
Study Description
Brief Summary: The study is designed as a Phase III, multi-center trial of tandem autologous transplants versus the strategy of autologous followed by Human Leukocyte Antigen (HLA)-matched sibling non-myeloablative allogeneic transplant. Study subjects will be biologically assigned to the appropriate arm depending on the availability of an HLA-matched sibling. There is a nested randomized phase III trial of observation versus maintenance therapy following the second autologous transplant for patients on the tandem autologous transplant arm.
Detailed Description: Multiple myeloma (MM), characterized by malignant plasma cell proliferation, bone destruction, and immunodeficiency, is a disease with a median age at diagnosis of approximately 65 years. It is responsible for about 1 percent of all cancer-related deaths in Western Countries. Conventional treatments with chemotherapy and radiation therapy are non-curative but improve quality of life and duration of survival. Attempts to cure myeloma through high-dose therapy followed by autografting or allografting have largely failed due to a combination of relapsed disease or transplant related mortality (TRM). High-dose therapy with autologous transplantation is safe and has low TRM (less than 5%), but is associated with a continuing and nearly universal risk of disease progression and relapse. Even so, autologous transplantation is superior to continued conventional chemotherapy. Recent data indicate that tandem autologous transplants are superior to a single procedure. Even with this approach, patients remain at risk of relapse and additional approaches are needed. DESIGN NARRATIVE: The overall study design is that of biologic assignment, based on the availability of an HLA-matched sibling, to one of two treatment strategies for MM patients. Patients without an HLA-matched sibling will undergo tandem autologous transplants. Patients with an HLA-matched sibling will undergo an autologous transplant followed by a non-myeloablative allogeneic transplant. In addition, the tandem autologous transplant recipients will be randomized to either observation or one year of maintenance therapy to begin following the second autologous transplant. The large number of MM patients without an HLA-matched sibling enables us to evaluate the role of maintenance therapy following tandem autologous transplants.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
City of Hope Samaritan, Phoenix, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
Scripps Clinic/Green Hospital, La Jolla, California, United States
UCSD Medical Center, La Jolla, California, United States
Stanford Hospital and Clinics, Stanford, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
University of Florida College of Medicine (Shands), Gainesville, Florida, United States
Emory University, Atlanta, Georgia, United States
BMT Group of Georgia/Northside Hospital, Atlanta, Georgia, United States
Loyola University, Maywood, Illinois, United States
IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health, Indianapolis, Indiana, United States
Wichita CCOP, Wichita, Kansas, United States
Tufts - New England Medical Center, Boston, Massachusetts, United States
DFCI/Brigham & Women's, Boston, Massachusetts, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Jewish Hospital BMT Program, Cincinnati, Ohio, United States
University Hospitals of Cleveland/Case Western, Cleveland, Ohio, United States
University of Oklahoma Medical Center, Oklahoma City, Oklahoma, United States
Oregon Health Sciences University (A), Portland, Oregon, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Fox Chase - Temple University - BMT Program, Philadelphia, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
Baylor College of Medicine/The Methodist Hospital, Houston, Texas, United States
University of Texas/MD Anderson Cancer Research Center, Houston, Texas, United States
Texas Transplant Institute, San Antonio, Texas, United States
Utah BMT/Univ of Utah Med School, Salt Lake City, Utah, United States
Virginia Commonwealth University MCV Hospitals, Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
University of Wisconsin Hospitals & 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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