The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma
Official Title: A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma With Thalidomide Plus Dexamethasone Salvage Therapy for Non-Responders
Study ID: NCT00098475
Brief Summary: This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.
Detailed Description: PRIMARY OBJECTIVE: I. To evaluate the response rate and toxicity of lenalidomide (CC-5013) plus dexamethasone (standard dose) versus CC-5013 plus low dose dexamethasone in patients with newly diagnosed myeloma at any time in the first 4 cycles of treatment and to determine if CC-5013 plus low dose dexamethasone will have similar response rate with lower toxicity (First Phase). SECONDARY OBJECTIVES: I. To evaluate the response rate of thalidomide plus dexamethasone (Thal/Dex) in patients with newly diagnosed myeloma who do not achieve a complete or partial response at any time in the first 4 cycles with the CC-5013 and dexamethasone combination in either of the two arms (First Phase). II. To study the effect of CC-5013 on bone marrow microvessel density and angiogenesis grade, on plasma cell labeling index (PCLI), and on the expression of vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the marrow (First Phase). III. To study the effect of CC-5013 and dexamethasone on bone marrow mesenchymal progenitor cells (MPCs) (First Phase). IV. To evaluate in a separate expansion phase the efficacy of aspirin (325 mg/day) versus Coumadin (dose adjusted to maintain a target international normalized ratio \[INR\] of 2-3) in preventing deep vein thrombosis (DVT) in patients with newly diagnosed myeloma receiving CC-5013 plus standard dose dexamethasone. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21, and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20. Arm II: Patients receive lenalidomide as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22. In both arms, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients not responding at any point during the first 4 cycles of lenalidomide and dexamethasone are assigned to 1 of 2 salvage therapy arms. Patients who progress during treatment on Arms I or II have the option to register on salvage therapy Arms III or IV respectively. Arm III (patients with no response after treatment on Arm I): Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20. Arm IV (patients with no response after treatment on Arm II): Patients receive thalidomide as in Arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22. In both salvage therapy arms, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of 4 cycles of therapy, patients may undergo stem cell harvest (using growth factors only) for cryopreservation. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Huntsville Hospital, Huntsville, Alabama, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
Saint Jude Medical Center, Fullerton, California, United States
El Camino Hospital, Mountain View, California, United States
Kaiser Permanente-San Diego Mission, San Diego, California, United States
The Medical Center of Aurora, Aurora, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
SCL Health Saint Joseph Hospital, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
Banner McKee Medical Center, Loveland, Colorado, United States
Danbury Hospital, Danbury, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Martin Hospital South, Stuart, Florida, United States
Phoebe Putney Memorial Hospital, Albany, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Atlanta Regional CCOP, Atlanta, Georgia, United States
Augusta Oncology Associates PC-D'Antignac, Augusta, Georgia, United States
Dekalb Medical Center, Decatur, Georgia, United States
Atrium Health Navicent, Macon, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States
Saint Anthony's Health, Alton, Illinois, United States
Northwestern University, Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Ascension Alexian Brothers - Elk Grove Village, Elk Grove Village, Illinois, United States
Edward Hines Jr VA Hospital, Hines, Illinois, United States
Midwest Center for Hematology Oncology, Joliet, Illinois, United States
Duly Health and Care Joliet, Joliet, Illinois, United States
Swedish American Hospital, Rockford, Illinois, United States
UW Health Carbone Cancer Center Rockford, Rockford, Illinois, United States
Edward H Kaplan MD and Associates, Skokie, Illinois, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Franciscan Health Indianapolis, Indianapolis, Indiana, United States
IU Health Arnett Cancer Care, Lafayette, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
McFarland Clinic - Ames, Ames, Iowa, United States
University of Iowa Healthcare Cancer Services Quad Cities, Bettendorf, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
MercyOne Waterloo Cancer Center, Waterloo, Iowa, United States
Kansas City NCI Community Oncology Research Program, Prairie Village, Kansas, United States
Harold Alfond Center for Cancer Care, Augusta, Maine, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
HealthAlliance Hospital - Leominster, Leominster, Massachusetts, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Saint Louis-Cape Girardeau CCOP, Saint Louis, Missouri, United States
Montana Cancer Consortium NCORP, Billings, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Nebraska Cancer Research Center, Lincoln, Nebraska, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States
Midlands Community Hospital, Papillion, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
The Cancer Institute of New Jersey Hamilton, Hamilton, New Jersey, United States
Morristown Medical Center, Morristown, New Jersey, United States
Virtua Memorial, Mount Holly, New Jersey, United States
Jersey Shore Medical Center, Neptune, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Robert Wood Johnson University Hospital Somerset, Somerville, New Jersey, United States
Garnet Health Medical Center, Middletown, New York, United States
NYU Langone Hospital - Long Island, Mineola, New York, United States
Mount Sinai Union Square, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Mission Hospital, Asheville, North Carolina, United States
Wayne Memorial Hospital, Goldsboro, North Carolina, United States
Southeast Clinical Oncology Research Consortium NCORP, Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Essentia Health Cancer Center-South University Clinic, Fargo, North Dakota, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Summa Health System - Akron Campus, Akron, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Miami Valley Hospital North, Dayton, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Saint Charles Hospital, Oregon, Ohio, United States
Firelands Regional Medical Center, Sandusky, Ohio, United States
ProMedica Flower Hospital, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States
Kaiser Permanente Northwest, Portland, Oregon, United States
Jefferson Abington Hospital, Abington, Pennsylvania, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
Lancaster General Hospital, Lancaster, Pennsylvania, United States
Saint Mary Medical and Regional Cancer Center, Langhorne, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Chestnut Hill Health System, Philadelphia, Pennsylvania, United States
Einstein Medical Center Philadelphia, Philadelphia, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer Hospital, Sayre, Pennsylvania, United States
Grand View Hospital, Sellersville, Pennsylvania, United States
Mount Nittany Medical Center, State College, Pennsylvania, United States
Reading Hospital, West Reading, Pennsylvania, United States
Lankenau Medical Center, Wynnewood, Pennsylvania, United States
WellSpan Health-York Hospital, York, Pennsylvania, United States
McLeod Regional Medical Center, Florence, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sentara Martha Jefferson Hospital, Charlottesville, Virginia, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Centra Alan B Pearson Regional Cancer Center, Lynchburg, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
West Virginia University Healthcare, Morgantown, West Virginia, United States
ThedaCare Regional Cancer Center, Appleton, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
SSM Health Dean Medical Group - South Madison Campus, Madison, 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
ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States
ProHealth Waukesha Memorial Hospital, Waukesha, Wisconsin, United States
Name: S. V Rajkumar
Affiliation: ECOG-ACRIN Cancer Research Group
Role: PRINCIPAL_INVESTIGATOR