A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma
OBJECTIVES:
- Compare the response rate of patients with newly diagnosed multiple myeloma treated
with dexamethasone with or without thalidomide.
- Compare the toxicity of these regimens in these patients.
- Assess the effect of thalidomide on bone marrow microvessel density and angiogenesis
grade and on the expression of vascular endothelial growth factor and basic fibroblast
growth factor in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive oral thalidomide once daily on days 1-28 and oral dexamethasone
once daily on days 1-4, 9-12, and 17-20. Patients also receive either pamidronate IV
over 2-4 hours or zoledronate IV over 15 minutes on day 1 for bone strengthening.
- Arm II: Patients receive dexamethasone and pamidronate or zoledronate as in arm I.
Treatment in both arms repeats every 28 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients may receive additional courses after the
fourth course at the physician's discretion.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 2 years.
PROJECTED ACCRUAL: A total of 194 patients (97 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
S. V. Rajkumar, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000069274
NCT00033332
April 2002
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Stanford University Medical Center | Stanford, California 94305-5408 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
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 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
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 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
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 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
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 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Veterans Affairs Medical Center - New York | New York, New York 10010 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
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 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
Veterans Affairs Medical Center - Pittsburgh | Pittsburgh, Pennsylvania 15240 |
Veterans Affairs Medical Center - Miami | Miami, Florida 33125 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
James P. Wilmot Cancer Center | Rochester, New York 14642 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Tuft-New England Medical Center | Boston, Massachusetts 02111 |
Albert Einstein Clinical Cancer Center | Bronx, New York 10461 |
Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | Nashville, Tennessee 37212 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
MBCCOP-Our Lady of Mercy Cancer Center | Bronx, New York 10466 |
Veterans Affairs Medical Center - Gainesville | Gainesville, Florida 32608-1197 |
Veterans Affairs Medical Center - Omaha | Omaha, Nebraska 68105 |
UF Shands Cancer Center | Gainesville, Florida 32610-0277 |