Study Stopped
Slow accrual
Bortezomib and Dexamethasone With or Without Lenalidomide in Treating Patients With Multiple Myeloma Previously Treated With Dexamethasone
Randomized Phase III Trial of Consolidation Therapy With Bortezomib (Velcade®)-Lenalidomide (Revlimid®) -Dexamethasone (VRD) Versus Bortezomib (Velcade®)-Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen
4 other identifiers
interventional
48
2 countries
276
Brief Summary
This randomized phase III trial compares bortezomib, dexamethasone, and lenalidomide with bortezomib and dexamethasone to see how well they work in treating patients with multiple myeloma previously treated with dexamethasone. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bortezomib and dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2007
Longer than P75 for phase_3
276 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2007
CompletedFirst Posted
Study publicly available on registry
August 29, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
June 26, 2015
CompletedJune 26, 2015
May 1, 2015
4.9 years
August 28, 2007
March 5, 2015
June 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
Progression-free survival was defined as the time from randomization to the earliest documentation of disease progression (PD) or death. If a patient died without evidence of PD, the patient was considered an event if death occurred within 3 months of the last disease assessment. Patients who died outside of the specified interval or patients who were alive without evidence of PD were censored at the date of last disease assessment. The PFS results are based on data as of August 2012, while overall survival (OS) was updated in April 2014. Given the early termination and limited sample size, data management efforts to update PFS were not pursued.
Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years
Secondary Outcomes (3)
Response Rates (Complete Response [CR] or Very Good Partial Response [VGPR])
Assessed at the end of each cycle, every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years
Overall Survival (OS)
Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years
Change in Quality of Life (QOL) From Baseline to 6 Months Post Consolidation as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI)
Baseline and 6 months post consolidation treatment
Study Arms (2)
Arm A (VRD)
EXPERIMENTALPatients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
Arm B (VD)
ACTIVE COMPARATORPatients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
Interventions
Given PO
Eligibility Criteria
You may qualify if:
- Symptomatic multiple myeloma, that was symptomatic at time of initial diagnosis, but may be asymptomatic at the time of registration based on induction therapy
- For the original diagnosis of myeloma, patients must have met the following criteria at one point in their disease course: bone marrow plasmacytosis (\>10% plasma cells or sheets of plasma cells) or a biopsy proven plasmacytoma, and evidence of end-organ damage due to multiple myeloma including anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fractures) or renal dysfunction.
- Patients may have prior exposure to bortezomib
- Patients must have received a minimum of 1 cycle, maximum of 6 cycles, of a dexamethasone-based regimen; patient must not have experienced progressive disease on such therapy
- The following induction regimens were considered adequate for enrollment: dexamethasone alone; vincristine, doxorubicin and dexamethasone; thalidomide and dexamethasone; lenalidomide and dexamethasone; liposomal doxorubicin and dexamethasone; the combination of any of the above agents and dexamethasone; or cyclophosphamide, lenalidomide and dexamethasone
- Patients must have received the minimum cumulative dose of dexamethasone of 160 mg (sum of induction treatment) with no maximum dose specified
- Patients must have been offered and refused front-line stem cell transplant OR not have been eligible for front-line stem cell transplant.
- Bone marrow aspiration and/or biopsy must be obtained =\< 28 days prior to randomization
- All tests below must be performed =\< 28 days prior to randomization:
- Kappa free light chain mg/dL
- Lambda free light chain mg/dL
- Serum M-protein by serum protein electrophoresis (SPEP)
- Urine M-protein light chain excretion by urine protein electrophoresis (UPEP)
- Adequate laboratory levels within 7 days prior to randomization: hemoglobin \> 7 g/dL, platelet count \> 75,000 cells/mm\^3, absolute neutrophil count \> 1000 cells/mm\^3, creatinine \< 2.5 mg/dL, creatinine clearance (measured or calculated) \>= 60 mL/min, direct bilirubin =\< 1.5 mg/dL, serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2.5 times the upper limit of normal
- Patients may be receiving bisphosphonates or erythropoietin growth factors (erythropoietic agents) for multiple myeloma
- +7 more criteria
You may not qualify if:
- More than 8 weeks from the last day of last cycle of induction treatment
- Active, uncontrolled seizure disorder; seizures in the last 6 months
- Uncontrolled inter-current illness that would limit compliance with the study including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation, prior history of Stevens Johnson syndrome
- Grade 2 or higher peripheral neuropathy by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
- Active, uncontrolled infection
- Smoldering myeloma or monoclonal gammopathy of undetermined significance
- Pregnant or nursing women were not eligible. Women of child-bearing potential unwilling to use a dual method of contraception and men who were unwilling to use a condom were not eligible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (276)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Northbay Cancer Center
Fairfield, California, 94533, United States
Kaiser Permanente
San Diego, California, 92120, United States
Stanford University Hospitals and Clinics
Stanford, California, 94305, 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
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Exempla Saint Joseph Hospital
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Colorado Cancer Research Program CCOP
Denver, Colorado, 80224-2522, 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
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, 30165, United States
Saint Anthony's Health
Alton, Illinois, 62002, 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
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Alexian Brothers Medical and Cancer Center
Elk Grove Village, Illinois, 60007, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Saint Francis Hospital
Evanston, Illinois, 60202, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
Illinois CancerCare Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, 61747, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, 61265, United States
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, 61265, United States
Sharis, Christine M MD (UIA Investigator)
Moline, Illinois, 61265, United States
Stoffel, Thomas J MD (UIA Investigator)
Moline, Illinois, 61265, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, 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
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois Oncology Research Association CCOP
Peoria, Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Saint Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
Carle Clinic-Urbana Main
Urbana, Illinois, 61801, United States
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
Reid Hospital and Health Care Services
Richmond, Indiana, 47374, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, 50010, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722, United States
Mercy Capitol
Des Moines, Iowa, 50307, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa Oncology Research Association CCOP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Hematology Oncology Associates
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51104, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Covenant Medical Center
Waterloo, Iowa, 50702, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Doctors Carrol, Sheth, Raghavan
Louisville, Kentucky, 40215, United States
Union Hospital of Cecil County
Elkton MD, Maryland, 21921, United States
Bixby Medical Center
Adrian, Michigan, 49221, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, 48106, United States
Oakwood Hospital
Dearborn, Michigan, 48124, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49431, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital
Monroe, Michigan, 48162, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, 55102, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Woodwinds Health Campus
Woodbury, Minnesota, 55125, United States
Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Capital Regional Medical Center
Jefferson City, Missouri, 65101, United States
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, 65802, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Saint John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Montana Cancer Consortium CCOP
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, 59102, United States
Billings Clinic
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Hospital
Missoula, Montana, 59801, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
Good Samaritan Hospital
Kearney, Nebraska, 68847, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, 08060, United States
Virtua West Jersey Hospital Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Kings County Hospital
Brooklyn, New York, 11203, United States
State University of New York Downstate Medical Center
Brooklyn, New York, 11203, United States
University Hospital of Brooklyn
Brooklyn, New York, 11203, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Adirondack Cancer Center
Glens Falls, New York, 12801, United States
Orange Regional Medical Center
Middletown, New York, 10940, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, 58122, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, 58122, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402, United States
Mercy Medical Center
Canton, Ohio, 44708, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Dayton CCOP
Dayton, Ohio, 45420, United States
Veteran Affairs Medical Center
Dayton, Ohio, 45428, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Fremont Memorial Hospital
Fremont, Ohio, 43420, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Saint Luke's Hospital
Maumee, Ohio, 43537, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, 43537, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Fisher-Titus Medical Center
Norwalk, Ohio, 44857, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616, United States
Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
University of Toledo
Toledo, Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
Mercy Saint Anne Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis HealthCare System
Zanesville, Ohio, 43701, United States
Adventist Medical Center
Portland, Oregon, 97216, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, 19464, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711, United States
Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Mainline Health CCOP
Wynnewood, Pennsylvania, 19096, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310, United States
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, 99336, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical PLLC
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
The Polyclinic
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
The Schiffler Cancer Center of Wheeling Hospital
Wheeling, West Virginia, 26003, United States
Wheeling Hospital
Wheeling, West Virginia, 26003, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Gundersen Lutheran
La Crosse, Wisconsin, 54601, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, 54154, 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
Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
University Of Pretoria
Pretoria, 0002, South Africa
Related Publications (1)
Fonseca R, Rajkumar SV. Consolidation therapy with bortezomib/lenalidomide/ dexamethasone versus bortezomib/dexamethasone after a dexamethasone-based induction regimen in patients with multiple myeloma: a randomized phase III trial. Clin Lymphoma Myeloma. 2008 Oct;8(5):315-7. doi: 10.3816/CLM.2008.n.046.
PMID: 18854289BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- STUDY CHAIR
Rafael Fonseca, M.D.
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2007
First Posted
August 29, 2007
Study Start
September 1, 2007
Primary Completion
August 1, 2012
Study Completion
July 1, 2014
Last Updated
June 26, 2015
Results First Posted
June 26, 2015
Record last verified: 2015-05