Phase II Study Of PS-341 For Patients With High-Risk, Newly Diagnosed Multiple Myeloma
OBJECTIVES:
Primary
- Determine the response rate in patients with newly diagnosed high-risk stage III
multiple myeloma treated with bortezomib induction therapy.
Secondary
- Determine the progression-free survival of patients treated with this drug.
- Determine the response rate and duration of second response in patients who relapse or
progress while on maintenance therapy and subsequently receive reinduction therapy with
this drug.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive bortezomib intravenously (IV) over 3-5 seconds on
days 1, 4, 8, and 11. Treatment repeats every 3 weeks for 8 courses in the absence of
disease progression or unacceptable toxicity. Patients who experience disease
progression must complete at least 2 courses of induction therapy. Patients who achieve
complete remission receive 2 additional courses, but no more than 8 courses total, and
then proceed to maintenance therapy.
- Maintenance therapy: Patients receive bortezomib IV over 3-5 seconds on days 1 and 15.
Courses repeat every 4 weeks in the absence of disease progression or unacceptable
toxicity. Patients who experience disease progression may return to induction therapy
(reinduction therapy).
- Reinduction therapy: Patients receive bortezomib as in induction therapy. Courses
repeat every 3 weeks until second disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years from
study entry.
ACTUAL ACCRUAL: A total of 44 patients were accrued for this study.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate on Induction
Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.
participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days
No
Angela Dispenzieri, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000349450
NCT00075881
January 2004
May 2011
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Evanston | Evanston, Illinois 60201 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Cancer Center at Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - New York | New York, New York 10010 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
Veterans Affairs Medical Center - Pittsburgh | Pittsburgh, Pennsylvania 15240 |
Veterans Affairs Medical Center - Miami | Miami, Florida 33125 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Midlands Cancer Center at Midlands Community Hospital | Papillion, Nebraska 68128-4157 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
Stanford Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | Nashville, Tennessee 37212 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
MBCCOP-Our Lady of Mercy Cancer Center | Bronx, New York 10466 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Veterans Affairs Medical Center - Gainesville | Gainesville, Florida 32608-1197 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Burgess Health Center | Onawa, Iowa 51040 |
Veterans Affairs Medical Center - Omaha | Omaha, Nebraska 68105 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Martin Memorial Cancer Center | Stuart, Florida 34995-9010 |