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| Sponsor: | Millennium Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00507416 |
Purpose
This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of VELCADE dexamethasone versus VELCADE, thalidomide, and dexamethasone versus VELCADE, melphalan, and prednisone in patients with previously untreated multiple myeloma who are not considered candidates for high-dose chemotherapy and autologous stem cell transplantation. This study will consist of a Screening period (generally 4 weeks or less), an Induction Treatment period (approximately 6 months), a Maintenance Treatment period (approximately 6 months), and a Post-treatment period.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: bortezomib, thalidomide, and dexamethasone (VTD) Drug: bortezomib and dexamethasone (VD) Drug: bortezomib, melphalan and prednisone (VMP) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE,Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone |
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Bortezomib, Thalidomide, and Dexamethasone (VTD): Experimental |
Drug: bortezomib, thalidomide, and dexamethasone (VTD)
bortezomib intravenously on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8. Thalidomide orally on Days 1-21 of a 21-day cycle during Cycles 1-8. Dexamethasone orally once daily (QD) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle during Cycles 1-4 (ie, on the day of and day after bortezomib administration), and then orally QD on Days 1, 2, 4, and 5 of a 21-day cycle during Cycles 5-8 Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive bortezomib intravenously on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13. |
| Bortezomib and Dexamethasone (VD): Experimental |
Drug: bortezomib and dexamethasone (VD)
bortezomib intravenously on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8. Dexamethasone orally once daily (QD) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle during Cycles 1-4 (ie, on the day of and day after bortezomib administration), and then orally QD on Days 1, 2, 4, and 5 of a 21-day cycle during Cycles 5-8. Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive bortezomib intravenously on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13. |
| Bortezomib, melphalan, and prednisone (VMP): Experimental |
Drug: bortezomib, melphalan and prednisone (VMP)
bortezomib administered intravenously on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8. Melphalan: orally once daily (QD) on Days 1-4 every other cycle during Cycles 1-8. Prednisone:orally QD on Days 1-4 every other cycle during Cycles 1-8. Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive bortezomib intravenously on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center | 1-866-835-2233 | medical@mlnm.com |
Hide Study Locations| United States, Alabama | |
| Birmingham Hematology Oncology Assciates, LLC | Recruiting |
| Birmingham, Alabama, United States, 35205 | |
| Southern Cancer Center | Withdrawn |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Desert Oasis Cancer Center | Recruiting |
| Casa Grande, Arizona, United States, 85222 | |
| Northern Arizona Hematology & Oncology Associates - AOA | Recruiting |
| Sedona, Arizona, United States, 86336 | |
| Arizona Oncology Associates | Recruiting |
| Tucson, Arizona, United States, 85704 | |
| United States, Arkansas | |
| Heritage Physician Group Oncology | Recruiting |
| Hot Springs, Arkansas, United States, 71913 | |
| Hematology Oncology Services of Arkansas | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Pacific Cancer Medical Centre | Recruiting |
| Anaheim, California, United States, 92801 | |
| Beaver Medical Group | Recruiting |
| Highland, California, United States, 92346 | |
| Compassionate Cancer Care Medical Group | Recruiting |
| Corona, California, United States, 92882 | |
| Compassionate Cancer Care Medical Group, Inc. | Recruiting |
| Fountain Valley, California, United States, 92708 | |
| Robert A. Moss, MD, FACP, Inc. | Recruiting |
| Fountain Valley, California, United States, 92708 | |
| Cancer Care Associates | Recruiting |
| Fresno, California, United States, 93720 | |
| Glendale Memorial Hospital & Health Center | Recruiting |
| Glendale, California, United States, 91204 | |
| California Cancer Care | Recruiting |
| Greenbrae, California, United States, 94904 | |
| Tower Cancer Research Foundation | Recruiting |
| Beverly Hills, California, United States, 90211-1850 | |
| Contact: Peter Rosen | |
| Scripps Cancer Center | Withdrawn |
| La Jolla, California, United States, 92037 | |
| Wilshire Oncology Medical Group | Withdrawn |
| La Verne, California, United States, 91750 | |
| Edward A. Wagner, MD | Recruiting |
| Laguna Beach, California, United States, 92882 | |
| Clinical Trials and Research Associates, Inc. | Recruiting |
| Montebello, California, United States, 90640 | |
| Medical Oncology Care Associates | Recruiting |
| Orange, California, United States, 92868 | |
| Compassionate Cancer Care Medical Group, Inc. | Recruiting |
| Riverside, California, United States, 92501 | |
| Southwest Cancer Care | Recruiting |
| Poway, California, United States, 92064 | |
| Desert Cancer Care, Incorporated | Recruiting |
| Rancho Mirage, California, United States, 92270 | |
| Ventura County Hematology Oncology Specialists | Recruiting |
| Oxnard, California, United States, 93030 | |
| Sutter Cancer Center | Recruiting |
| Sacramento, California, United States, 95816 | |
| Contact: Michael Carroll | |
| Cancer Research & Prevention Center | Recruiting |
| Soquel, California, United States, 95073 | |
| Stockton Hematology/Oncology | Recruiting |
| Stockton, California, United States, 95204 | |
| Trivalley Oncology Hematology | Recruiting |
| Westlake Village, California, United States, 91361 | |
| Contact: Ashwin Kashyap, MD | |
| United States, Colorado | |
| Rocky Mountain Cancer Center | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Front Range Cancer Specialists | Withdrawn |
| Fort Collins, Colorado, United States, 80528 | |
| United States, Connecticut | |
| Cancer Center of Central Connecticut | Recruiting |
| Southington, Connecticut, United States, 06489 | |
| United States, Delaware | |
| Christiana Care Health Services | Recruiting |
| Newark, Delaware, United States, 19718 | |
| United States, Florida | |
| The Center for Hematology-Oncology | Recruiting |
| Boca Raton, Florida, United States, 33486 | |
| Pasco Hernando Oncology | Recruiting |
| Brooksville, Florida, United States, 34613 | |
| Northwest Oncology & Hematology Associates | Recruiting |
| Coral Springs, Florida, United States, 33065 | |
| Florida Cancer Specialists | Recruiting |
| Fort Myers, Florida, United States, 33901 | |
| Contact: James Reeves, MD | |
| Horizon Institute for Clinical Research | Recruiting |
| Hollywood, Florida, United States, 33021 | |
| University of Florida- Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32209 | |
| Contact: Fauzia Rana | |
| Baptist Cancer Institute | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Cancer Care of North Florida | Recruiting |
| Lake City, Florida, United States, 32024 | |
| Lakeland Regional Cancer Center | Recruiting |
| Lakeland, Florida, United States, 33805 | |
| MD Anderson Cancer Center Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Advanced Medical Specialties | Withdrawn |
| Miami, Florida, United States, 33176 | |
| Pasco Hernando Oncology | Recruiting |
| New Port Richey, Florida, United States, 34652 | |
| Florida Cancer Institute | Recruiting |
| New Port Richey, Florida, United States, 34655 | |
| Innovative Medical Research of South Florida Inc. | Recruiting |
| North Miami Beach, Florida, United States, 33179 | |
| Ocala Oncology Center | Recruiting |
| Ocala, Florida, United States, 34474 | |
| Cancer Centers of Florida, P.A. | Recruiting |
| Ocoee, Florida, United States, 34761 | |
| Cancer & Blood Disease Center | Recruiting |
| Lecanto, Florida, United States, 34461 | |
| Hematology Oncology Associates of the Treasure Coast, PA | Recruiting |
| Port St. Lucie, Florida, United States, 34952 | |
| Gulfcoast Oncology Associates | Recruiting |
| St. Petersburg, Florida, United States, 33705 | |
| Stuart Oncology | Withdrawn |
| Stuart, Florida, United States, 34994 | |
| S. Florida Oncology/ Hematology | Recruiting |
| West Palm Beach, Florida, United States, 33458 | |
| Contact: Lawrence Tepper | |
| United States, Georgia | |
| Medical Oncology Associates of Augusta | Recruiting |
| Augusta, Georgia, United States, 30901 | |
| Piedmont Hospital | Withdrawn |
| Atlanta, Georgia, United States, 30309 | |
| Augusta Oncology | Withdrawn |
| Augusta, Georgia, United States, 30901 | |
| Northeast Georgia Cancer Care, LLC | Withdrawn |
| Athens, Georgia, United States, 30607 | |
| Suburban Hematology/Oncology Associates | Withdrawn |
| Lawrenceville, Georgia, United States, 30045 | |
| Central Georgia Cancer Care | Recruiting |
| Macon, Georgia, United States, 31201 | |
| Northwest Georgia Oncology Centers, P.C. | Recruiting |
| Marietta, Georgia, United States, 30060 | |
| Summit Cancer Care | Recruiting |
| Savannah, Georgia, United States, 31405 | |
| United States, Idaho | |
| St. Lukes Mountain States Tumor Institute | Recruiting |
| Boise, Idaho, United States, 83712 | |
| Contact: Theodore Walters | |
| Snake River Oncology of Eastern Idaho, PLLC. | Recruiting |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| Cancer Care & Hematology Specialists of Chicagoland | Recruiting |
| Arlington Heights, Illinois, United States, 60005 | |
| Hematology Oncology Associates of Illinois | Recruiting |
| Chicago, Illinois, United States, 60657 | |
| University of Chicago | Not yet recruiting |
| Chicago, Illinois, United States, 60637 | |
| John H. Stroger, Jr. Hospital of Cook County | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Hematology Oncology Associates of Illinois | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Elmhurst Memorial Hospital | Recruiting |
| Elmhurst, Illinois, United States, 60126 | |
| Oncology Hematology Associates of North Illinois Ltd. | Recruiting |
| Gurnee, Illinois, United States, 60031-3399 | |
| Contact: Nilesh Mehta | |
| Cancer Care and Hematology Specialists of Chicagoland | Recruiting |
| Niles, Illinois, United States, 60714 | |
| Joliet Oncology-Hematology Associates, Ltd. | Recruiting |
| Joliet, Illinois, United States, 60435 | |
| Hematology Oncology Consultants, Inc. | Recruiting |
| Naperville, Illinois, United States, 60540 | |
| Midwest Center for Hematology / Oncology | Recruiting |
| Joliet, Illinois, United States, 60432 | |
| Mid-Illinois Hem & Onc | Recruiting |
| Normal, Illinois, United States, 61761 | |
| Quincy Medical Group | Recruiting |
| Quincy, Illinois, United States, 62301 | |
| United States, Indiana | |
| Deaconess Clinic Incorporated | Recruiting |
| Evansville, Indiana, United States, 47713 | |
| Investigative Clinical Research of Indiana, LLC | Recruiting |
| Indianapolis, Indiana, United States, 46254 | |
| Cancer Care Center | Recruiting |
| New Albany, Indiana, United States, 47150 | |
| Clarian Arnett Cancer Center | Recruiting |
| Lafayette, Indiana, United States, 47904 | |
| Medical Consultants, PC | Recruiting |
| Muncie, Indiana, United States, 47303 | |
| Central Indiana Cancer Centers | Recruiting |
| Indianapolis, Indiana, United States, 46227 | |
| Memorial Hospital of South Bend | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: Robin Zon | |
| Hope Center | Recruiting |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Iowa | |
| McFarland Clinic, P.C. | Recruiting |
| Ames, Iowa, United States, 50010 | |
| Heartland Hematology-Oncology Associates, Inc. | Recruiting |
| Council Bluffs, Iowa, United States, 51503 | |
| Siouxland Hematology/Oncology Assoc., LLP | Recruiting |
| Sioux City, Iowa, United States, 51101 | |
| United States, Kansas | |
| Kansas City Cancer Centers - Southwest | Recruiting |
| Overland Park, Kansas, United States, 66210 | |
| Cancer Center of Kansas | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| Commonwealth Cancer Center | Recruiting |
| Danville, Kentucky, United States, 40422 | |
| Kentucky Cancer Clinic | Recruiting |
| Hazard, Kentucky, United States, 41701 | |
| Kentuckianna Cancer Institute, PLLC | Withdrawn |
| Louisville, Kentucky, United States, 40202 | |
| Oncology Associates of West Kentucky | Withdrawn |
| Paducah, Kentucky, United States, 42003 | |
| Western Kentucky Hematology and Oncology Group | Recruiting |
| Paducah, Kentucky, United States, 42003 | |
| Contact: William Skinner, MD | |
| United States, Louisiana | |
| Christus St. Francis Cabrini Cancer Center | Recruiting |
| Alexandria, Louisiana, United States, 71301 | |
| Hematology-Oncology Clinic | Recruiting |
| Baton Rouge, Louisiana, United States, 70809 | |
| Jayne S. Gurtler, MD, Laura A. Brinz, MD, and Angelo Russo, MD APMC | Withdrawn |
| Metairie, Louisiana, United States, 70006-2921 | |
| United States, Maine | |
| Maine Center for Cancer Medicine & Blood Disorders | Withdrawn |
| Sanford, Maine, United States, 04073 | |
| United States, Maryland | |
| Annapolis Oncology Center | Recruiting |
| Annapolis, Maryland, United States, 21401 | |
| Auerbach Hematology Oncology Associates | Recruiting |
| Baltimore, Maryland, United States, 21237 | |
| Greater Baltimore Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21204 | |
| St. Agnes Health Care | Recruiting |
| Baltimore, Maryland, United States, 21229 | |
| Maryland Hematology Oncology Association | Recruiting |
| Baltimore, Maryland, United States, 21237 | |
| Center for Cancer and Blood Disorders | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| Oncology-Hematology Associates, P.A. | Recruiting |
| Clinton, Maryland, United States, 20735 | |
| Maryland Oncology Hematology, PA | Recruiting |
| Columbia, Maryland, United States, 21044 | |
| Carroll County Cancer Center | Recruiting |
| Westminster, Maryland, United States, 21157 | |
| United States, Massachusetts | |
| Boston Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Fallon Clinic at Worcester Medical Center | Recruiting |
| Worcester, Massachusetts, United States, 01608-1320 | |
| United States, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Cancer & Hematology Centers of Western Michigan | Recruiting |
| Grand Rapids, Michigan, United States, 49546 | |
| Kalamazoo Hematology and Oncology | Recruiting |
| Kalamazoo, Michigan, United States, 49048 | |
| Oncology Care Associates, P.L.L.C. | Recruiting |
| St. Joseph, Michigan, United States, 49085 | |
| Breslin Cancer Center / Great Lakes Cancer Institute | Not yet recruiting |
| Lansing, Michigan, United States, 48910 | |
| Providence Cancer Center | Recruiting |
| Southfield, Michigan, United States, 48075 | |
| Contact: Howard Terebelo | |
| Hematology Oncology Associates of Ohio & Michigan, PC | Recruiting |
| Lambertville, Michigan, United States, 48144 | |
| Osteopathic Medical Hematology & Oncology | Recruiting |
| Woodhaven, Michigan, United States, 48183 | |
| United States, Minnesota | |
| St. Luke's Hospital | Recruiting |
| Duluth, Minnesota, United States, 55805 | |
| Metro MN CCOP | Recruiting |
| Minneapolis, Minnesota, United States, 55416 | |
| Hubert H. Humphrey Cancer Center | Recruiting |
| Robbinsdale, Minnesota, United States, 55422 | |
| United States, Missouri | |
| Capital Region Medical Center/Cancer Center | Recruiting |
| Jefferson City, Missouri, United States, 65109 | |
| Ellis Fischel Cancer Center | Withdrawn |
| Columbia, Missouri, United States, 65203 | |
| Missouri Cancer Associates | Withdrawn |
| Columbia, Missouri, United States, 65201 | |
| St. Louis Cancer Center | Recruiting |
| Chesterfield, Missouri, United States, 63017 | |
| Contact: Daniel Cuevas | |
| Heartland Hematology-Oncology Associates, Inc. | Recruiting |
| Kansas City, Missouri, United States, 64118 | |
| Kansas City Veterans Administration Medical Center | Recruiting |
| Kansas City, Missouri, United States, 64128 | |
| St. Joseph Oncology | Recruiting |
| St. Joseph, Missouri, United States, 64507 | |
| St. Louis Cancer and Breast Institute | Withdrawn |
| St. Louis, Missouri, United States, 63141 | |
| Center for Cancer Care and Research | Withdrawn |
| St. Louis, Missouri, United States, 63141 | |
| United States, Montana | |
| Billings Clinic | Withdrawn |
| Billings, Montana, United States, 59101 | |
| Hematology Oncology Centers of the Northern Rockies | Withdrawn |
| Billings, Montana, United States, 59101 | |
| Great Falls Clinic, LLP | Recruiting |
| Great Falls, Montana, United States, 59405 | |
| United States, Nebraska | |
| Nebraska Cancer Care | Withdrawn |
| Hastings, Nebraska, United States, 68901 | |
| Great Plains Regional Medical Center | Recruiting |
| North Platte, Nebraska, United States, 69101 | |
| Hematology & Oncology | Withdrawn |
| Omaha, Nebraska, United States, 68122 | |
| Creighton Cancer Center | Not yet recruiting |
| Omaha, Nebraska, United States, 68131-2137 | |
| United States, Nevada | |
| Las Vegas Cancer Center | Recruiting |
| Henderson, Nevada, United States, 89052 | |
| Comprehensive Cancer Centers of Nevada | Recruiting |
| Las Vegas, Nevada, United States, 89169 | |
| United States, New Jersey | |
| Veterans Affairs New Jersey Healthcare System | Recruiting |
| East Orange, New Jersey, United States, 07018 | |
| Contact: Shanthi Srinivas | |
| Drs. Forte, Schleider, Attas and Condemi, PA | Recruiting |
| Englewood, New Jersey, United States, 07631 | |
| St. Barnabas Medical Center | Recruiting |
| Livingston, New Jersey, United States, 07039 | |
| Newark Beth Israel Hospital | Recruiting |
| Newark, New Jersey, United States, 07112 | |
| Contact: Susan Talbot | |
| Somerset Hematology Oncology Associates | Recruiting |
| Somerville, New Jersey, United States, 08876 | |
| Contact: Steven Young | |
| Sparta Cancer Center | Recruiting |
| Sparta, New Jersey, United States, 07871 | |
| United States, New Mexico | |
| New Mexico Cancer Care Associates | Recruiting |
| Santa Fe, New Mexico, United States, 87505 | |
| United States, New York | |
| Erie County Medical Center | Recruiting |
| Buffalo, New York, United States, 14215 | |
| Dr. Fernando J. Camacho, Private Practice | Withdrawn |
| Bronx, New York, United States, 10467 | |
| Eastchester Center for Cancer Care | Recruiting |
| Bronx, New York, United States, 10469 | |
| Stratton VA Medical Center IRB | Recruiting |
| Albany, New York, United States, 12208 | |
| Contact: Donald Pasquale | |
| Buffalo Institute for Medical Research, Inc. | Recruiting |
| Buffalo, New York, United States, 14215 | |
| Goshen Medical Associates | Recruiting |
| Goshen, New York, United States, 10924 | |
| Huntington Medical Group | Recruiting |
| Huntington Station, New York, United States, 11746 | |
| North Shore-Long Island Jewish Health System | Recruiting |
| Lake Success, New York, United States, 11042 | |
| Arena Oncology Associates | Recruiting |
| New Hyde Park, New York, United States, 11042 | |
| Richmond University Medical Center | Recruiting |
| Staten Island, New York, United States, 10301 | |
| New York Presbyterian Hospital-Cornell Campus | Recruiting |
| New York, New York, United States, 10021 | |
| Interlakes Foundation, Inc. | Recruiting |
| Rochester, New York, United States, 14623 | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10021 | |
| SUNY Upstate Medical University | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Bernard Poiesz | |
| New York Medical College | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Karen Seiter | |
| United States, North Carolina | |
| Cancer Care of WNC | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Alamance Regional Medical Center | Recruiting |
| Burlington, North Carolina, United States, 27215 | |
| Emerywood Hematology/Oncology | Recruiting |
| High Point, North Carolina, United States, 27262 | |
| Gaston Hematology & Oncology | Recruiting |
| Gastonia, North Carolina, United States, 28054 | |
| Carolina Oncology Specialist, PA | Recruiting |
| Hickory, North Carolina, United States, 28603 | |
| Blood and Cancer Clinic | Recruiting |
| Fayetteville, North Carolina, United States, 28304 | |
| Raleigh Hematology Oncology / Associates, P.C. | Recruiting |
| Raleigh, North Carolina, United States, 27607 | |
| Hanover Medical Specialists, P.A. | Recruiting |
| Wilmington, North Carolina, United States, 28401 | |
| United States, North Dakota | |
| Legacy Pharma Research | Withdrawn |
| Bismarck, North Dakota, United States, 58501 | |
| St. Alexius Clinical Research Services | Recruiting |
| Bismark, North Dakota, United States, 58501 | |
| United States, Ohio | |
| Summa Health System | Withdrawn |
| Akron, Ohio, United States, 44309 | |
| Oncology Hematology Care, Inc. | Recruiting |
| Cincinnati, Ohio, United States, 45215 | |
| Gabrail Cancer Center | Recruiting |
| Canton, Ohio, United States, 44718 | |
| Oncology Partners Network | Recruiting |
| Cincinnati, Ohio, United States, 45247 | |
| Contact: James Maher | |
| Blood and Cancer Center, Inc. | Withdrawn |
| Canfield, Ohio, United States, 44406 | |
| University Hospitals of Cleveland | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Hematology Oncology Consultants Inc. | Recruiting |
| Columbus, Ohio, United States, 43235 | |
| Dayton Clinical Oncology Program | Recruiting |
| Dayton, Ohio, United States, 45429 | |
| Dayton Oncology & Hematology | Recruiting |
| Kettering, Ohio, United States, 45409 | |
| Toledo Community Hospital Oncology Program | Recruiting |
| Toledo, Ohio, United States, 43617 | |
| Trilogy Cancer Center | Recruiting |
| Wooster, Ohio, United States, 44691 | |
| United States, Oklahoma | |
| Cancer Care Associates | Recruiting |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Oklahoma Oncology and Hematology | Recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Bend Memorial Clinic | Withdrawn |
| Bend, Oregon, United States, 97701 | |
| Willamette Valley Cancer Center | Recruiting |
| Eugene, Oregon, United States, 97401 | |
| Pacific Oncology | Withdrawn |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Onc-Hem of Lehigh Valley, PC | Recruiting |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Regional Hematology Oncology Associates | Recruiting |
| Langhorne, Pennsylvania, United States, 19047 | |
| Hematology & Oncology Associates of NEPA | Recruiting |
| Dunmore, Pennsylvania, United States, 18512 | |
| Contact: William Jordan, MD | |
| Medical Oncology Associates | Recruiting |
| Kingston, Pennsylvania, United States, 18704 | |
| Consultants in Medical Oncology & Hematology | Withdrawn |
| Drexel Hill, Pennsylvania, United States, 19026 | |
| Greater Philadelphia Cancer and Hematology Specialists, PC | Recruiting |
| Philadelphia, Pennsylvania, United States, 19114 | |
| UPMC Cancer Pavillioin | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Suzanne Lentzsch | |
| Guthrie Research Institute | Recruiting |
| Sayre, Pennsylvania, United States, 18840 | |
| Scranton Hematology Oncology | Recruiting |
| Scranton, Pennsylvania, United States, 18510 | |
| United States, Rhode Island | |
| Roger Williams Medical Center | Recruiting |
| Providence, Rhode Island, United States, 02908 | |
| Contact: Frank Cummings | |
| United States, South Carolina | |
| MUSC Hollings Cancer Center | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Robert Stuart | |
| South Carolina Oncology Associates | Withdrawn |
| Columbia, South Carolina, United States, 29210 | |
| Cancer Center of the Carolinas | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Low Country Hematology & Oncology | Recruiting |
| Mt. Pleasant, South Carolina, United States, 29464 | |
| Santee Hematology/Oncology | Recruiting |
| Sumter, South Carolina, United States, 29150 | |
| United States, South Dakota | |
| Avera Research Institute | Recruiting |
| Sioux Falls, South Dakota, United States, 57105 | |
| United States, Tennessee | |
| Chattanooga Oncology Hematology Associates | Recruiting |
| Chattanooga, Tennessee, United States, 37404 | |
| The Family Cancer Center, PLLC | Recruiting |
| Collierville, Tennessee, United States, 38017 | |
| Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| The Jones Clinic | Recruiting |
| Germantown, Tennessee, United States, 38138 | |
| University of Tennesee Medical Center | Recruiting |
| Knoxville, Tennessee, United States, 37920 | |
| East Tennessee Oncology/Hematology | Recruiting |
| Knoxville, Tennessee, United States, 37920 | |
| The Cancer Center of Cookeville Regional Medical Center | Recruiting |
| Cookeville, Tennessee, United States, 38501 | |
| United States, Texas | |
| Texas Cancer Center | Recruiting |
| Abilene, Texas, United States, 79606-5208 | |
| Texas Oncology, P.A. | Recruiting |
| Arlington, Texas, United States, 76014 | |
| Southwest Regional Cancer Center | Recruiting |
| Austin, Texas, United States, 78705 | |
| Texas Oncology, PA | Recruiting |
| Austin, Texas, United States, 78731 | |
| Texas Oncology, PA | Recruiting |
| Beaumont, Texas, United States, 77702 | |
| Texas Oncology, P.A. | Recruiting |
| Bedford, Texas, United States, 76022 | |
| South Texas Institute of Cancer and Blood Disorders | Recruiting |
| Corpus Christi, Texas, United States, 78405 | |
| Texas Cancer Center of Mesquite | Recruiting |
| Mesquite, Texas, United States, 75150 | |
| Coastal Bend Cancer Center | Recruiting |
| Corpus Christi, Texas, United States, 73112 | |
| Dallas Oncology Consultants | Recruiting |
| Dallas, Texas, United States, 75237 | |
| Center for Oncology Research and Treatment, Pa | Withdrawn |
| Dallas, Texas, United States, 75230 | |
| Texas Oncology, PA / Methodist Charlton Cancer Center | Recruiting |
| Dallas, Texas, United States, 75237 | |
| Texas Oncology | Recruiting |
| Dallas, Texas, United States, 75230-2510 | |
| Texas Oncology PA | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Texas Cancer Center | Recruiting |
| Denton, Texas, United States, 76210 | |
| El Paso Cancer Treatment Center | Recruiting |
| El Paso, Texas, United States, 79902 | |
| Texas Cancer Center | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Texas Oncology, PA | Recruiting |
| Garland, Texas, United States, 75042 | |
| Lee C. Drinkard, MD | Recruiting |
| Grapevine, Texas, United States, 76051 | |
| Medicus Alliance Clinical Research Organization, LLC | Recruiting |
| Houston, Texas, United States, 77090 | |
| Houston Cancer Institute | Recruiting |
| Houston, Texas, United States, 77055 | |
| Lake Vista Cancer Center | Recruiting |
| Lewisville, Texas, United States, 75067 | |
| Longview Cancer Center | Recruiting |
| Longview, Texas, United States, 75601 | |
| Cancer Specialists of South Texas, P.A. | Withdrawn |
| Corpus Christi, Texas, United States, 78412 | |
| Texas Oncology, P.A. | Recruiting |
| Midland, Texas, United States, 79701 | |
| Texas Oncology - Odessa | Recruiting |
| Odessa, Texas, United States, 79761 | |
| Paris Regional Cancer Center | Recruiting |
| Paris, Texas, United States, 75460 | |
| Cancer Care Center of South Texas | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Cancer Care Network of South Texas | Recruiting |
| San Antonio, Texas, United States, 78217 | |
| Tyler Hematology/Oncology, PA | Recruiting |
| Tyler, Texas, United States, 75701 | |
| Texas Cancer Center - Sherman | Recruiting |
| Sherman, Texas, United States, 75090 | |
| Blood and Cancer Center of East Texas | Recruiting |
| Tyler, Texas, United States, 75701 | |
| CTRC Institute for Drug Development | Recruiting |
| San Antonio, Texas, United States, 78245 | |
| Texas Oncology, PA | Recruiting |
| Tyler, Texas, United States, 75702 | |
| Texas Oncology | Recruiting |
| Waco, Texas, United States, 76712 | |
| United States, Utah | |
| Northern Utah Associates | Recruiting |
| Ogden, Utah, United States, 84403 | |
| Utah Cancer Specialists | Recruiting |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Vermont | |
| The University of Vermont | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| White River Junction VAMC | Recruiting |
| White River Junction, Vermont, United States, 05009-001 | |
| Contact: Stefan Balan, MD | |
| United States, Virginia | |
| Cancer Specialists of Tidewater | Recruiting |
| Chesapeake, Virginia, United States, 23320 | |
| Fairfax/Northern Virginia Hematology/Oncology | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| Lynchburg Hematology Oncology Clinic, Inc. | Recruiting |
| Lynchburg, Virginia, United States, 24501 | |
| Peninsula Cancer Institute Riverside Cancer Center | Recruiting |
| Newport News, Virginia, United States, 23601 | |
| Virginia Oncology Associates | Recruiting |
| Norfolk, Virginia, United States, 23502 | |
| Virginia Cancer Institute | Recruiting |
| Richmond, Virginia, United States, 23230 | |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | Recruiting |
| Salem, Virginia, United States, 24153 | |
| Masoom Kandahari, MD, PC | Recruiting |
| Woodbridge, Virginia, United States, 22191 | |
| United States, Washington | |
| Puget Sound Cancer Center - Edmonds | Recruiting |
| Edmonds, Washington, United States, 98026 | |
| Providence Everett Medical Center | Recruiting |
| Everett, Washington, United States, 98201 | |
| Puget Sound Cancer Center, Inc | Recruiting |
| Seattle, Washington, United States, 98133 | |
| Cancer Care Northwest, US Oncology | Recruiting |
| Spokane, Washington, United States, 99202 | |
| Northwest Medical Specialties, PLLC | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Wenatchee Valley Medical Center | Recruiting |
| Wenatchee, Washington, United States, 98801 | |
| Yakima Valley Memorial Hospital / North Star Lodge | Recruiting |
| Yakima, Washington, United States, 98902 | |
| United States, Wisconsin | |
| Gundersen Clinic, Ltd. | Recruiting |
| La Crosse, Wisconsin, United States, 54601 | |
| Alyce & Elmore Kraemer Cancer Center | Recruiting |
| West Bend, Wisconsin, United States, 53095 | |
| Puerto Rico | |
| Hospital Auxillo Mutuo, Auxilio Mutuo Cancer Center | Recruiting |
| San Juan, Puerto Rico, 00919-1227 | |
| Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
More Information
| Responsible Party: | Millennium Pharmaceuticals, Inc. ( Clinical Study Medical Monitor ) |
| Study ID Numbers: | C05009 |
| Study First Received: | July 25, 2007 |
| Last Updated: | December 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00507416 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Dexamethasone Anti-Inflammatory Agents Prednisone Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Angiogenesis Modulating Agents Immunoproliferative Disorders Immune System Diseases |
Antineoplastic Agents, Hormonal Hematologic Diseases Glucocorticoids Multiple Myeloma Protease Inhibitors Neoplasms Leprostatic Agents Melphalan Thalidomide Immunologic Factors Blood Protein Disorders Antineoplastic Agents Paraproteinemias Hemostatic Disorders Anti-Bacterial Agents |