A Phase II Study of Bortezomib, Liposomal Doxorubicin, Dexamethasone, and Cyclophosphamide in Patients With Multiple Myeloma Relapsing Within 12 Months of Autologous Stem Cell Transplant
PRIMARY OBJECTIVES:
I. To evaluate the 1-year survival of patients with relapsed multiple myeloma treated with
bortezomib, pegylated liposomal doxorubicin hydrochloride, dexamethasone, and
cyclophosphamide.
SECONDARY OBJECTIVES:
I. To evaluate response rates in patients treated with this regimen. II. To evaluate the
median time to progression in patients treated with this regimen.
III. To evaluate the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV on days 1, 4, 8, and 11; pegylated liposomal doxorubicin
hydrochloride IV over 1 hour on day 4; oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and
12; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to
12 courses in the absence of disease progression or unacceptable toxicity.
Peripheral blood and bone marrow samples may be collected for future research. Patients
complete the FACT neurotoxicity questionnaire periodically.
After completion of study treatment, patients are followed up every 3 months for 3 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
One-year overall survival
Estimated using the method of Kaplan and Meier
1 year
No
Shaji Kumar
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2011-02002
NCT01078441
September 2010
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
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 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Center of Central Georgia | Macon, Georgia 31201 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Beebe Medical Center | Lewes, Delaware 19958 |
Memorial Hospital | Carthage, Illinois 62321 |
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 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Fulton County Health Center | Wauseon, Ohio 43567 |
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 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Bixby Medical Center | Adrian, Michigan 49221 |
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 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Fisher-Titus Medical Center | Norwalk, Ohio 44857 |
UW Cancer Center Johnson Creek | Johnson Creek, Wisconsin 53038 |
Longmont United Hospital | Longmont, Colorado 80501 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Cancer Center of Kansas - McPherson | McPherson, Kansas 67460 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Flower Hospital | Sylvania, Ohio 43560-2197 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Butler Memorial Hospital | Butler, Pennsylvania 16001 |
Littleton Adventist Hospital | Littleton, Colorado 80122 |
Parker Adventist Hospital | Parker, Colorado 80138 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
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 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
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 CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Hickman Cancer Center | Adrian, Michigan 49221 |
Mercy Memorial Hospital | Monroe, Michigan 48162 |
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 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Hematology Oncology Center Incorporated | Elyria, Ohio 44035 |
Saint Charles Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care | Sandusky, Ohio 44870 |
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 |
Saint Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Fredericksburg Oncology Inc | Fredericksburg, Virginia 22401 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
North Coast Cancer Care-Clyde | Clyde, Ohio 43410 |
Community Health Partners Regional Medical Center | Elyria, Ohio 44035 |
The Jewish Hospital | Cincinnati, Ohio 45236 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |
The Toledo Hospital/Toledo Children's Hospital | Toledo, Ohio 43606 |
Toledo Clinic Cancer Centers-Oregon | Oregon, Ohio 43616 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |
Illinois CancerCare Galesburg | Galesburg, Illinois 61401 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Toledo Clinic Cancer Centers-Bowling Green | Bowling Green, Ohio 43402 |
Toledo Clinic Cancer Centers-Maumee | Maumee, Ohio 43537-1839 |
Toledo Clinic Cancer Centers-Toledo | Toledo, Ohio 43623 |