Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00033332
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma.
PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (78)
Veterans Affairs Medical Center - Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Veterans Affairs Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Tuft-New England Medical Center
🇺🇸Boston, Massachusetts, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
UF Shands Cancer Center
🇺🇸Gainesville, Florida, United States
MBCCOP - Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
Veterans Affairs Medical Center - Palo Alto
🇺🇸Palo Alto, California, United States
Veterans Affairs Medical Center - Gainesville
🇺🇸Gainesville, Florida, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Veterans Affairs Medical Center - New York
🇺🇸New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
MBCCOP-Our Lady of Mercy Cancer Center
🇺🇸Bronx, New York, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Veterans Affairs Medical Center - Brooklyn
🇺🇸Brooklyn, New York, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
Veterans Affairs Medical Center - Miami
🇺🇸Miami, Florida, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Veterans Affairs Medical Center - Omaha
🇺🇸Omaha, Nebraska, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
MBCCOP - San Juan
🇵🇷San Juan, Puerto Rico
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States
Pretoria Academic Hospitals
🇿🇦Pretoria, South Africa
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
Veterans Affairs Medical Center - San Juan
🇵🇷San Juan, Puerto Rico
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
🇺🇸Nashville, Tennessee, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States