Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
NCT ID: NCT00033332
Last Updated: 2014-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2002-04-30
2006-06-30
Brief Summary
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PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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dexamethasone
pamidronate disodium
thalidomide
zoledronic acid
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed symptomatic multiple myeloma confirmed by the following:
* Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytosis
* Monoclonal protein (M protein) at least 1.0 g/dL on serum protein electrophoresis or at least 200 mg of monoclonal light chain on a 24-hour urine protein electrophoresis
* No smoldering myeloma or monoclonal gammopathy of undetermined significance
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 50,000/mm\^3
* Hemoglobin greater than 7 g/dL
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* ALT and AST no greater than 2.5 times upper limit of normal
Renal:
* Creatinine less than 3 mg/dL
Cardiovascular:
* No prior or concurrent deep venous thrombosis
Other:
* Prior malignancy allowed provided the following criteria are met:
* Received prior treatment with curative intent
* Free of disease for the time period appropriate for cure of the specific cancer
* No grade 2 or greater peripheral neuropathy due to other medical conditions
* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 1 highly effective method and 1 additional method of contraception for 1 month before, during, and for 4 weeks after study for women and effective barrier contraception for men during and for 4 weeks after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy for multiple myeloma
* No other concurrent biologic therapy for multiple myeloma
Chemotherapy:
* No prior chemotherapy for multiple myeloma
* No other concurrent chemotherapy for multiple myeloma
Endocrine therapy:
* More than 6 months since prior systemic dexamethasone or glucocorticoids
* No concurrent corticosteroids
Radiotherapy:
* At least 4 weeks since prior palliative, localized radiotherapy
* Concurrent palliative, localized radiotherapy allowed at the physician's discretion
Surgery:
* Not specified
Other:
* No prior systemic therapy for multiple myeloma, except bisphosphonates
* No concurrent anticoagulant therapy for deep vein thrombosis
* No concurrent barbiturates or alcohol (thalidomide arm)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Principal Investigators
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S. V. Rajkumar, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States
Stanford University Medical Center
Stanford, California, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Gainesville
Gainesville, Florida, United States
UF Shands Cancer Center
Gainesville, Florida, United States
Veterans Affairs Medical Center - Miami
Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Tuft-New England Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 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
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 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
James P. Wilmot Cancer Center
Rochester, New York, United States
Albert Einstein Clinical Cancer Center
The Bronx, New York, United States
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
MBCCOP - San Juan
San Juan, , Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan, , Puerto Rico
Pretoria Academic Hospitals
Pretoria, , South Africa
Countries
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References
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Ballester O. The emperor's new clothes or the current practice of clinical trials for multiple myeloma in the USA. Cancer Invest. 2008 Jun;26(5):445-7. doi: 10.1080/07357900701874641.
Johnson DC, Corthals S, Ramos C, Hoering A, Cocks K, Dickens NJ, Haessler J, Goldschmidt H, Child JA, Bell SE, Jackson G, Baris D, Rajkumar SV, Davies FE, Durie BG, Crowley J, Sonneveld P, Van Ness B, Morgan GJ. Genetic associations with thalidomide mediated venous thrombotic events in myeloma identified using targeted genotyping. Blood. 2008 Dec 15;112(13):4924-34. doi: 10.1182/blood-2008-02-140434. Epub 2008 Sep 19.
Kumar S, Greipp PR, Haug JL, et al.: Correlation of bone marrow angiogenesis and response to thalidomide dexamethasone in multiple myeloma. [Abstract] J Clin Oncol 24 (Suppl 18): A-7621, 451s, 2006.
Rajkumar SV, Blood E, Vesole D, Fonseca R, Greipp PR; Eastern Cooperative Oncology Group. Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma: a clinical trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2006 Jan 20;24(3):431-6. doi: 10.1200/JCO.2005.03.0221. Epub 2005 Dec 19.
Greipp PR. Eastern Cooperative Oncology Group E1A00: phase III randomized study of dexamethasone with or without thalidomide in patients with newly diagnosed multiple myeloma. Clin Adv Hematol Oncol. 2003 Mar;1(3):188-9. No abstract available.
Other Identifiers
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E-E1A00
Identifier Type: -
Identifier Source: secondary_id
CDR0000069274
Identifier Type: -
Identifier Source: org_study_id
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