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
PRIMARY OBJECTIVES:
I. To compare the progression-free survival (PFS) of patients with previously treated
symptomatic multiple myeloma treated with consolidation therapy comprising bortezomib and
dexamethasone with vs without lenalidomide.
SECONDARY OBJECTIVES:
I. To determine the incremental ability of these regimens in attaining a complete response
or a very good partial response (VGPR) in these patients.
II. To compare the overall survival of patients treated with these regimens. III. To compare
the toxicity of these regimens in these patients. IV. To compare the quality of life of
these patients. V. To examine the impact of differential treatment response, if observed, on
quality of life of these patients.
VI. To obtain prospective data on multiple myeloma specific quality of life attributes.
OUTLINE: Patients are stratified according to prior induction therapy with lenalidomide and
dexamethasone (yes vs no) and whether or not they are in complete response after induction
therapy at study registration (yes vs no). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive bortezomib IV on days 1, 4, 8, and 11, oral lenalidomide once a day
on days 1-14, and oral dexamethasone once a day on days 1-4. Treatment repeats every 21 days
for 8 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral dexamethasone once a
day on days 1-4. Treatment repeats every 21 days for 8 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed periodically. After completion of study treatment, patients are
followed every 3 months for 2 years, every 6 months for 3 years, and then every 12 months
for 5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PFS of two consolidation regimens
PFS in each of the arms will be estimated using the method of Kaplan and Meier. PFS between the two arms will be compared using one-sided stratified log-rank test.
Time from consolidation randomization until progression or death of any cause, assessed up to 10 years
No
Rafael Fonseca
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2009-00521
NCT00522392
August 2007
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Stanford University | Stanford, California 94305 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
Wesley Medical Center | Wichita, Kansas 67214 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Great Falls Clinic | Great Falls, Montana 59405 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Harborview Medical Center | Seattle, Washington 98104 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Beebe Medical Center | Lewes, Delaware 19958 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
MeritCare Medical Group | Fargo, North Dakota 58122 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Grandview Hospital | Dayton, Ohio 45405 |
Fremont Memorial Hospital | Fremont, Ohio 43420 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Firelands Regional Medical Center | Sandusky, Ohio 44870 |
Mercy Medical Center | Springfield, Ohio 45504 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Eureka Hospital | Eureka, Illinois 61530 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Graham Hospital Association | Canton, Illinois 61520 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Pekin Hospital | Pekin, Illinois 61554 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Bixby Medical Center | Adrian, Michigan 49221 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
Saint Luke's Hospital | Maumee, Ohio 43537 |
Lancaster General Hospital | Lancaster, Pennsylvania 17604-3555 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Franciscan Skemp Healthcare | La Crosse, Wisconsin 54601-4796 |
Center for Cancer Care and Research | St. Louis, Missouri 63141 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Northern Montana Hospital | Havre, Montana 59501 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Wayne Hospital | Greenville, Ohio 45331 |
Fisher-Titus Medical Center | Norwalk, Ohio 44857 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Adventist Medical Center | Portland, Oregon 97216 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
UW Cancer Center Johnson Creek | Johnson Creek, Wisconsin 53038 |
Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Longmont United Hospital | Longmont, Colorado 80501 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Memorial Medical Center | Springfield, Illinois 62781 |
Doylestown Hospital | Doylestown, Pennsylvania 18901 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Case Western Reserve University | Cleveland, Ohio 44106 |
Toledo Clinic | Oregon, Ohio 43616 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
Kaiser Permanente | Sacramento, California |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
University of New Mexico | Albuquerque, New Mexico 87131 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
Northbay Cancer Center | Fairfield, California 94533 |
The Medical Center of Aurora | Aurora, Colorado 80012 |
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado 80907 |
Saint Anthony Central Hospital | Denver, Colorado 80204 |
Exempla Saint Joseph Hospital | Denver, Colorado 80218 |
Colorado Cancer Research Program CCOP | Denver, Colorado 80224-2522 |
Saint Mary's Hospital and Regional Medical Center | Grand Junction, Colorado 81502 |
Saint Mary Corwin Medical Center | Pueblo, Colorado 81004 |
John B Amos Cancer Center | Columbus, Georgia 31904 |
Saint Anthony's Health | Alton, Illinois 62002 |
Cancer Institute at Alexian Brothers | Elk Grove Village, Illinois 60007 |
Saint Francis Hospital | Evanston, Illinois 60202 |
Intercommunity Cancer Center | Galesburg, Illinois 61401 |
Hopedale Medical Complex - Hospital | Hopedale, Illinois 61747 |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Stoffel, Thomas J MD (UIA Investigator) | Moline, Illinois 61265 |
Garneau, Stewart C MD (UIA Investigator) | Moline, Illinois 61265 |
Sharis, Christine M MD (UIA Investigator) | Moline, Illinois 61265 |
Porubcin, Michael MD (UIA Investigator) | Moline, Illinois 61265 |
Good Samaritan Regional Medical Center | Mt. Vernon, Illinois 62864 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Saint Margaret's Hospital | Spring Valley, Illinois 61362 |
Carle Clinic-Urbana Main | Urbana, Illinois 61801 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
McFarland Clinic | Ames, Iowa 50010 |
Constantinou, Costas L MD (UIA Investigator) | Bettendorf, Iowa 52722 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Capitol | Des Moines, Iowa 50307 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Siouxland Hematology - Oncology Associates | Sioux City, Iowa 51101 |
Covenant Medical Center | Waterloo, Iowa 50702 |
Hickman Cancer Center | Adrian, Michigan 49221 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Green Bay Oncology - Escanaba | Escanaba, Michigan 49431 |
Green Bay Oncology - Iron Mountain | Iron Mountain, Michigan 49801 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Memorial Hospital | Monroe, Michigan 48162 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Merit Care Clinic Bemidji | Bemidji, Minnesota 56601 |
Saint Mary's Medical Center | Duluth, Minnesota 55805 |
Miller-Dwan Hospital | Duluth, Minnesota 55805 |
Duluth Clinic CCOP | Duluth, Minnesota 55805 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Saint Joseph's Hospital - Healtheast | Saint Paul, Minnesota 55102 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Southeast Missouri Hospital | Cape Girardeau, Missouri 63701 |
Saint Louis-Cape Girardeau CCOP | Saint Louis, Missouri 63141 |
Missouri Baptist Medical Center | Saint Louis, Missouri 63131 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Saint Louis Cancer and Breast Institute | Saint Louis, Missouri 63109 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Berdeaux, Donald MD (UIA Investigator) | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Community Medical Hospital | Missoula, Montana 59801 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Good Samaritan Hospital | Kearney, Nebraska 68847 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Veterans Adminstration New Jersey Health Care System | East Orange, New Jersey 07018-1095 |
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly, New Jersey 08060 |
Virtua West Jersey Hospital Voorhees | Voorhees, New Jersey 08043 |
Adirondack Cancer Center | Glens Falls, New York 12801 |
Orange Regional Medical Center | Middletown, New York 10940 |
Meritcare Hospital | Fargo, North Dakota 58122 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Veteran Affairs Medical Center | Dayton, Ohio 45428 |
Hematology Oncology Center Incorporated | Elyria, Ohio 44035 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center | Maumee, Ohio 43537 |
Bayview Oncology Associates | Oregon, Ohio 43616 |
Saint Charles Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care | Sandusky, Ohio 44870 |
Flower Memorial Hospital | Sylvania, Ohio 43560 |
Toledo Community Hospital Oncology Program CCOP | Toledo, Ohio 43617 |
Mercy Cancer Center at Saint Anne Mercy Hospital | Toledo, Ohio 43623 |
University of Toledo | Toledo, Ohio 43614 |
The Toledo Hospital | Toledo, Ohio 43606 |
Saint Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
Geisinger South Wilkes Barre-Hazelton Cancer Center | Hazleton, Pennsylvania 18201 |
Pottstown Memorial Medical Center | Pottstown, Pennsylvania 19464 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Mainline Health CCOP | Wynnewood, Pennsylvania 19096 |
Fredericksburg Oncology Inc | Fredericksburg, Virginia 22401 |
Saint Joseph Hospital | Bellingham, Washington 98225 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
The Polyclinic | Seattle, Washington 98122 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Wheeling Hospital | Wheeling, West Virginia 26003 |
Sacred Heart Hospital | Eau Claire, Wisconsin 54701 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Marshfield Clinic-Minocqua Center | Minocqua, Wisconsin 54548 |
Green Bay Oncology - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Marshfield Clinic at James Beck Cancer Center | Rhinelander, Wisconsin 54501 |
Marshfield Clinic-Rice Lake Center | Rice Lake, Wisconsin 54868 |
Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Green Bay Oncology - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Marshfield Clinic-Wausau Center | Wausau, Wisconsin 54401 |
Christiana Healthcare Services - Christian Hospital | Newark, Delaware 19718 |
Harbin Clinic Medical Oncology and Clinical Research | Rome, Georgia 30165 |
University of Missouri - Ellis Fischel | Columbia, Missouri 65203 |
University of Tennessee - Knoxville | Knoxville, Tennessee 37920 |
Marshfield Clinic-Chippewa Center | Chippewa Falls, Wisconsin 54729 |
State University of New York Downstate Medical Center | Brooklyn, New York 11203 |
Capital Regional Medical Center | Jefferson City, Missouri 65101 |
Doctors Carrol, Sheth, Raghavan | Louisville, Kentucky 40215 |
Kings County Hospital | Brooklyn, New York 11203 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
University Hospital of Brooklyn | Brooklyn, New York 11203 |
The Schiffler Cancer Center of Wheeling Hospital | Wheeling, West Virginia 26003 |