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)
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Three-year progression-free survival (PFS)
The primary objective of the randomized trial is to compare PFS between the two single transplant arms and between each single transplant arm and the tandem transplant arm.
Measured at 3 years
Yes
Amrita Krishnan, MD
Study Chair
City of Hope National Medical Center
United States: Food and Drug Administration
690
NCT01109004
May 2010
May 2020
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
North Shore University Hospital | Manhasset, New York 11030 |
University of Rochester Medical Center | Rochester, New York 14642 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
Mount Sinai Medical Center | New York, New York 10029 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
University of Oklahoma | Oklahoma City, Oklahoma 73190 |
University of Minnesota | Minneapolis, Minnesota 55455 |
University of California, San Francisco | San Francisco, California 94143 |
Oregon Health & Science University | Portland, Oregon 97201 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Michigan Medical Center | Ann Arbor, Michigan 48104-0914 |
SUNY Upstate Medical University | Syracuse, New York 13210 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
University of Wisconsin Hospital & Clinics | Madison, Wisconsin 53792 |
Roswell Park Cancer Center | Buffalo, New York 14263 |
Louisiana State University Health Sciences Center | Shreveport, Louisiana 71130 |
University of Chicago | Chicago, Illinois 60637 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Texas Transplant Institute | San Antonio, Texas 78229 |
University of California, San Diego Medical Center | San Diego, California |
University of Miami | Miami, Florida 33136 |
St. Louis University | St. Louis, Missouri 63110 |
Stanford Hospital and Clinics | Stanford, California 94305 |
Karmanos Cancer Institute/BMT | Detroit, Michigan 48201 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
University of Kansas Hospital | Kansas City, Kansas 66160 |
University of Oklahoma Medical Center | Oklahoma City, Oklahoma 73104 |
Baylor College of Medicine/The Methodist Hospital | Houston, Texas 77030-2399 |
Columbia River Oncology Program | Portland, Oregon 97225 |
University of Illinois | Chicago, Illinois 60612 |
Blood and Marrow Transplant Program at Northside Hospital | Atlanta, Georgia 30342 |
Advocate Lutheran General Hospital | Park Ridge, Illinois 60068 |
University of Texas, MD Anderson CRC | Houston, Texas 77030 |
St. Lukes Mountain States Tumor Institute | Boise, Idaho 83712 |
University of North Carolina Hospital at Chapel Hill | Chapel Hill, North Carolina 27599 |
West Virginia University Hospital | Morgantown, West Virginia 26506-9162 |
University of Florida College of Medicine | Gainesville, Florida 32610 |
Colorado Blood Cancer Institute | Denver, Colorado 80218 |
Christiana Care Health System | Newark, Delaware 19713 |
DFCI, Massachusetts General Hospital | Boston, Massachusetts 02114 |
Washington University, Barnes Jewish Hospital | St. Louis, Missouri 63110 |
Georgia Health Sciences University | Augusta, Georgia 30912 |
Jewish Hospital BMT Program | Cincinnati, Ohio 45236 |
Banner Research Institute | Phoenix, Arizona 85006 |
Lahey Clinic | Burlington, Maine 01805 |
DFCI, Brigham and Womens Hospital | Boston, Massachusetts 02114 |
Ohio State | Columbus, Ohio 43210 |
Penn State College of Medicine, The Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
VA Tennessee Valley Healthcare | Nashville, Tennessee 53792-5156 |
Sarah Cannon Blood & Marrow Transplant Program | Nashville, Tennessee 37203 |