This randomized phase III trial studies lenalidomide to see how well it works compared to a
placebo in treating patients who are undergoing autologous stem cell transplant for multiple
myeloma. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any
cancer cells that are in the body and helps make room in the patient's bone marrow for new
blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the
patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for
the stem cell transplant. The stem cells are then returned to the patient to replace the
blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as
lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer
cells from growing. Giving lenalidomide after autologous stem cell transplant may be an
effective treatment for multiple myeloma.
30-60 minutes on day - 2 or -1 or over 2 days on days -3 and -2 or -2 and -1. Patients
undergo autologous PBSCT on day 0.
Patients are then randomized to 1 of 2 maintenance treatment arms. (Note: As of 12/17/09, no
more patients will be randomized between lenalidomide and placebo. Patients who have not
been randomized as of 12/17/09 will be assigned to lenalidomide.)
ARM I: Beginning between day 100-110, patients receive lenalidomide orally (PO) once daily.
ARM II: Beginning between day 100-110, patients receive placebo (PO) once daily.
In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year and
then every 6 months thereafter.
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Mayo Clinic in Arizona, Scottsdale, Arizona 85259, United States
City of Hope Comprehensive Cancer Center, Duarte, California 91010, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California 95817, United States
UCSF Medical Center-Mount Zion, San Francisco, California 94115, United States
The Medical Center of Aurora, Aurora, Colorado 80012, United States
Boulder Community Hospital, Boulder, Colorado 80301, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado 80907, United States
Colorado Cancer Research Program CCOP, Denver, Colorado 80224-2522, United States
Exempla Saint Joseph Hospital, Denver, Colorado 80218, United States
Porter Adventist Hospital, Denver, Colorado 80210, United States
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado 80218, United States
Rose Medical Center, Denver, Colorado 80220, United States
Swedish Medical Center, Englewood, Colorado 80113, United States
Saint Mary's Hospital and Regional Medical Center, Grand Junction, Colorado 81502, United States
North Colorado Medical Center, Greeley, Colorado 80631, United States
Saint Anthony Hospital, Lakewood, Colorado 80228, United States
Sky Ridge Medical Center, Lone Tree, Colorado 80124, United States
Longmont United Hospital, Longmont, Colorado 80501, United States
McKee Medical Center, Loveland, Colorado 80539, United States
Saint Mary Corwin Medical Center, Pueblo, Colorado 81004, United States
North Suburban Medical Center, Thornton, Colorado 80229, United States
Exempla Lutheran Medical Center, Wheat Ridge, Colorado 80033, United States
Saint Francis Hospital - Wilmington, Wilmington, Delaware 19805, United States
George Washington University Medical Center, Washington, District of Columbia 20037, United States
University of Florida, Gainesville, Florida 32610, United States
Mayo Clinic in Florida, Jacksonville, Florida 32224-9980, United States
Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia 30342, United States
Georgia Regents University Medical Center, Augusta, Georgia 30912, United States
Saint Joseph Medical Center, Bloomington, Illinois 61701, United States
Graham Hospital Association, Canton, Illinois 61520, United States
Memorial Hospital, Carthage, Illinois 62321, United States
Jesse Brown Veterans Affairs Medical Center, Chicago, Illinois 60612, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois 60637, United States
University of Illinois, Chicago, Illinois 60612, United States
Eureka Hospital, Eureka, Illinois 61530, United States
Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States
Illinois CancerCare Galesburg, Galesburg, Illinois 61401, United States
Mason District Hospital, Havana, Illinois 62644, United States
Hopedale Medical Complex - Hospital, Hopedale, Illinois 61747, United States
Kewanee Hospital, Kewanee, Illinois 61443, United States
Mcdonough District Hospital, Macomb, Illinois 61455, United States
Bromenn Regional Medical Center, Normal, Illinois 61761, United States
Community Cancer Center Foundation, Normal, Illinois 61761, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois 61350, United States
Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois 61350, United States
Pekin Cancer Treatment Center, Pekin, Illinois 61554, United States
Pekin Hospital, Pekin, Illinois 61554, United States
Illinois CancerCare-Peoria, Peoria, Illinois 61615, United States
Illinois Oncology Research Association CCOP, Peoria, Illinois 61615, United States
Methodist Medical Center of Illinois, Peoria, Illinois 61603, United States
OSF Saint Francis Medical Center, Peoria, Illinois 61637, United States
Proctor Hospital, Peoria, Illinois 61614, United States
Illinois Valley Hospital, Peru, Illinois 61354, United States
Perry Memorial Hospital, Princeton, Illinois 61356, United States
Saint Margaret's Hospital, Spring Valley, Illinois 61362, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202, United States
Providence Medical Center, Kansas City, Kansas 66112, United States
Lawrence Memorial Hospital, Lawrence, Kansas 66044, United States
Radiation Oncology Practice Corporation Southwest, Overland Park, Kansas 66210, United States
Walter Reed National Military Medical Center, Bethesda, Maryland 20889-5600, United States
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota 55455, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
University of Mississippi Medical Center, Jackson, Mississippi 39216, United States
Centerpoint Medical Center LLC, Independence, Missouri 64057, United States
Radiation Oncology Practice Corporation - North, Kansas City, Missouri 64154, United States
Radiation Oncology Practice Corporation South, Kansas City, Missouri 64114, United States
Saint Luke's Cancer Institute, Kansas City, Missouri 64111, United States
Liberty Radiation Oncology Center, Liberty, Missouri 64068, United States
Washington University School of Medicine, Saint Louis, Missouri 63110, United States
University of Nebraska Medical Center, Omaha, Nebraska 68198, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey 08903, United States
Albert Einstein College of Medicine, Bronx, New York 10461, United States
Montefiore Medical Center - Moses Campus, Bronx, New York 10467-2490, United States
Montefiore Medical Center-Wakefield Campus, Bronx, New York 10466, United States
Roswell Park Cancer Institute, Buffalo, New York 14263, United States
North Shore University Hospital, Manhasset, New York 11030, United States
North Shore-LIJ Health System NCORP, Manhasset, New York 11030, United States
Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States
Mount Sinai Medical Center, New York, New York 10029, United States
Weill Medical College of Cornell University, New York, New York 10065, United States
University of Rochester, Rochester, New York 14642, United States
State University of New York Upstate Medical University, Syracuse, New York 13210, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina 28203, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States
The Jewish Hospital, Cincinnati, Ohio 45236, United States
Case Western Reserve University, Cleveland, Ohio 44106, United States
MetroHealth Medical Center, Cleveland, Ohio 44109, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210, United States
Oregon Health and Science University, Portland, Oregon 97239, United States
Geisinger Medical Center, Danville, Pennsylvania 17822, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania 18201, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania 19104, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania 15232, United States
West Penn Hospital, Pittsburgh, Pennsylvania 15224, United States
Geisinger Medical Group, State College, Pennsylvania 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania 18711, United States
Greenville Memorial Hospital, Greenville, South Carolina 29605, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee 37232, United States
M D Anderson Cancer Center, Houston, Texas 77030, United States
LDS Hospital, Salt Lake City, Utah 84143, United States
Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont 05602, United States
University of Vermont College of Medicine, Burlington, Vermont 05405, United States
University of Washington Medical Center, Seattle, Washington 98195, United States
Saint Mary's Medical Center, Huntington, West Virginia 25702, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin 53792, United States
Marshfield Clinic, Marshfield, Wisconsin 54449, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States
Marshfield Clinic at James Beck Cancer Center, Rhinelander, Wisconsin 54501, United States
Marshfield Clinic-Rice Lake Center, Rice Lake, Wisconsin 54868, United States