Spots Global Cancer Trial Database for Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
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Trial Identification
Brief Title: Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
Official Title: A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 (NSC # 703813) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma
Study ID: NCT00114101
Study Description
Brief Summary: This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. 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.
Detailed Description: PRIMARY OBJECTIVE: I. To determine the efficacy of CC-5013 (lenalidomide) in prolonging time to disease progression in patients with multiple myeloma after autologous stem cell transplant (ASCT). SECONDARY OBJECTIVES: I. To determine if CC-5013 will increase the complete response (CR) rate in patients with multiple myeloma following ASCT. II. To compare the progression-free survival (PFS) and overall survival (OS) in patients with multiple myeloma who have undergone ASCT and who then are randomized to either CC-5013 or placebo. III. To determine the feasibility of long-term administration of CC-5013 to multiple myeloma patients who have undergone ASCT. OUTLINE: PERIPHERAL BLOOD STEM CELL (PBSC) MOBILIZATION: Mobilization of autologous PBSC will be performed according to institutional guidelines. AUTOLOGOUS PBSC TRANSPLANTATION (PBSCT): Patients receive melphalan intravenously (IV) over 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
UC San Diego Medical Center - Hillcrest, San Diego, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
The Medical Center of Aurora, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
SCL Health Saint Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
Western States Cancer Research NCORP, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Saint Mary's Hospital and Regional Medical Center, Grand Junction, Colorado, United States
Banner North Colorado Medical Center, Greeley, Colorado, United States
Saint Anthony Hospital, Lakewood, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Longmont United Hospital, Longmont, Colorado, United States
Banner McKee Medical Center, Loveland, Colorado, United States
Saint Mary Corwin Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Saint Francis Hospital - Wilmington, Wilmington, Delaware, United States
George Washington University Medical Center, Washington, District of Columbia, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Augusta University Medical Center, Augusta, Georgia, United States
Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States
OSF Saint Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital Association, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Jesse Brown Veterans Affairs Medical Center, Chicago, Illinois, United States
University of Illinois, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Heartland Cancer Research NCORP, Decatur, Illinois, United States
Eureka Hospital, Eureka, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hopedale Medical Complex - Hospital, Hopedale, Illinois, United States
Kewanee Hospital, Kewanee, Illinois, United States
Mcdonough District Hospital, Macomb, Illinois, United States
Bromenn Regional Medical Center, Normal, Illinois, United States
Carle Cancer Institute Normal, Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin, Pekin, Illinois, United States
Pekin Hospital, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois Valley Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
Saint Margaret's Hospital, Spring Valley, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Providence Medical Center, Kansas City, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Menorah Medical Center, Overland Park, Kansas, United States
Radiation Oncology Practice Corporation Southwest, Overland Park, Kansas, United States
Advent Health - Shawnee Mission Medical Center, Shawnee Mission, Kansas, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Christiana Care - Union Hospital, Elkton, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Lahey Hospital and Medical Center, Burlington, Massachusetts, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Centerpoint Medical Center LLC, Independence, Missouri, United States
University Health Truman Medical Center, Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States
Radiation Oncology Practice Corporation South, Kansas City, Missouri, United States
Saint Joseph Health Center, Kansas City, Missouri, United States
North Kansas City Hospital, Kansas City, Missouri, United States
Research Medical Center, Kansas City, Missouri, United States
Radiation Oncology Practice Corporation - North, Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit, Lee's Summit, Missouri, United States
Liberty Radiation Oncology Center, Liberty, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States
Montefiore Medical Center-Wakefield Campus, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Northwell Health NCORP, Lake Success, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Mount Sinai Hospital, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
NYP/Weill Cornell Medical Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
The Jewish Hospital, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
West Penn Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Saint Francis Hospital, Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Houston Methodist Hospital, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
LDS Hospital, Salt Lake City, Utah, United States
Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont, United States
University of Vermont and State Agricultural College, Burlington, Vermont, United States
Virginia Oncology Associates-Hampton, Hampton, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
Saint Mary's Medical Center, Huntington, West Virginia, United States
Aurora Cancer Care-Glendale, Glendale, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Ascension Saint Mary's Hospital, Rhinelander, Wisconsin, United States
Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States
Contact Details
Name: Philip L McCarthy
Affiliation: Alliance for Clinical Trials in Oncology
Role: PRINCIPAL_INVESTIGATOR
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