A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy Versus Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-myeloablative Allogeneic Stem Cell Transplant for Patients With Multiple Myeloma (BMT CTN #0102)
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Three-year progression-free survival
Measured at 3 years
Yes
David G. Maloney, MD, PhD
Study Chair
Fred Hutchinson Cancer Research Center
United States: Food and Drug Administration
417
NCT00075829
December 2003
March 2014
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Tufts - New England Medical Center | Boston, Massachusetts 02111 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Baylor University Medical Center | Dallas, Texas 75246 |
University of Minnesota | Minneapolis, Minnesota 55455 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Vanderbilt University | Nashville, Tennessee 37232-6305 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Michigan Medical Center | Ann Arbor, Michigan 48104-0914 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Texas Transplant Institute | San Antonio, Texas 78229 |
Kansas City Cancer Centers - Central | Kansas City, Missouri 64111 |
DeKalb Medical Center | Decatur, Georgia 30033 |
Loyola University | Maywood, Illinois 60153 |
UCSD Medical Center | La Jolla, California 92093 |
Stanford Hospital and Clinics | Stanford, California 94305 |
University of Florida College of Medicine (Shands) | Gainesville, Florida 32610 |
Washington University/Barnes Jewish Hospital | St. Louis, Missouri 63110 |
University Hospitals of Cleveland/Case Western | Cleveland, Ohio 44106 |
Indiana BMT at Beech Grove | Beech Grove, Indiana 46107 |
DFCI/Brigham & Women's | Boston, Massachusetts 02114 |
University of Oklahoma Medical Center | Oklahoma City, Oklahoma 73104 |
Baylor College of Medicine/The Methodist Hospital | Houston, Texas 77030-2399 |
Virginia Commonwealth University MCV Hospitals | Richmond, Virginia 23298-0037 |
City of Hope Samaritan | Phoenix, Arizona 85006 |
Scripps Clinic/Green Hospital | La Jolla, California 92037-1027 |
Rocky Mountain BMT | Denver, Colorado 80218 |
BMT Group of Georgia/Northside Hospital | Atlanta, Georgia 30342 |
Oregon Health Sciences University (A) | Portland, Oregon 97239-3098 |
Fox Chase - Temple University - BMT Program | Philadelphia, Pennsylvania 19111-2442 |
University of Texas/MD Anderson Cancer Research Center | Houston, Texas 77030 |
University of Wisconsin Hospitals & Clinics | Madison, Wisconsin 53792-6164 |