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Spots Global Cancer Trial Database for Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: S. V Rajkumar

Affiliation: ECOG-ACRIN Cancer Research Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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