- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00033332
Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00927-5800
- MBCCOP - San Juan
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San Juan, Puerto Rico, 00927-5800
- Veterans Affairs Medical Center - San Juan
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Pretoria, South Africa, 0001
- Pretoria Academic Hospitals
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Arizona
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Scottsdale, Arizona, United States, 85259-5404
- CCOP - Scottsdale Oncology Program
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California
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Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
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Palo Alto, California, United States, 94304-1290
- Veterans Affairs Medical Center - Palo Alto
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Stanford, California, United States, 94305-5408
- Stanford University Medical Center
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Colorado
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Denver, Colorado, United States, 80224
- CCOP - Colorado Cancer Research Program, Inc.
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Delaware
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Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20060
- MBCCOP - Howard University Cancer Center
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Florida
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Gainesville, Florida, United States, 32608-1197
- Veterans Affairs Medical Center - Gainesville
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Gainesville, Florida, United States, 32610-0277
- UF Shands Cancer Center
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Miami, Florida, United States, 33125
- Veterans Affairs Medical Center - Miami
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Tampa, Florida, United States, 33612
- Veterans Affairs Medical Center - Tampa (Haley)
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Decatur, Georgia, United States, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Illinois
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Chicago, Illinois, United States, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Chicago, Illinois, United States, 60611-4494
- Veterans Affairs Medical Center - Lakeside Chicago
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Evanston, Illinois, United States, 60201
- CCOP - Evanston
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Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, United States, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Bettendorf, Iowa, United States, 52722
- Hematology Oncology Associates of the Quad Cities
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center
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Kansas
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Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
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Louisiana
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, United States, 70121
- CCOP - Ochsner
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02111
- Tuft-New England Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Minneapolis, Minnesota, United States, 55417-2399
- Veterans Affairs Medical Center - Minneapolis
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, United States, 68105
- Veterans Affairs Medical Center - Omaha
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Jersey
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East Orange, New Jersey, United States, 07019
- Veterans Affairs Medical Center - East Orange
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Hackensack, New Jersey, United States, 07601
- CCOP - Northern New Jersey
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New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey
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New York
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Bronx, New York, United States, 10461
- Albert Einstein Clinical Cancer Center
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Bronx, New York, United States, 10466
- MBCCOP-Our Lady of Mercy Cancer Center
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Brooklyn, New York, United States, 11209
- Veterans Affairs Medical Center - Brooklyn
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New York, New York, United States, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, United States, 10010
- Veterans Affairs Medical Center - New York
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Rochester, New York, United States, 14642
- James P. Wilmot Cancer Center
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North Dakota
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Fargo, North Dakota, United States, 58122
- CCOP - Merit Care Hospital
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- CCOP - Oklahoma
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, United States, 19102-1192
- Hahnemann University Hospital
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Pittsburgh, Pennsylvania, United States, 15213-3489
- University of Pittsburgh Cancer Institute
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Pittsburgh, Pennsylvania, United States, 15240-0001
- Veterans Affairs Medical Center - Pittsburgh
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Wynnewood, Pennsylvania, United States, 19096
- CCOP - MainLine Health
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- CCOP - Sioux Community Cancer Consortium
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Tennessee
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Nashville, Tennessee, United States, 37232-6307
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, United States, 37212-2637
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
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Texas
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Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Madison, Wisconsin, United States, 53792-0001
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, United States, 53705-2286
- Veterans Affairs Medical Center - Madison
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Marshfield, Wisconsin, United States, 54449
- CCOP - Marshfield Medical Research and Education Foundation
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Milwaukee, Wisconsin, United States, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Milwaukee, Wisconsin, United States, 53226-3596
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: S. V. Rajkumar, MD, Mayo Clinic
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Bone Density Conservation Agents
- Dexamethasone
- Thalidomide
- Zoledronic Acid
- Pamidronate
Other Study ID Numbers
- CDR0000069274
- U10CA021115 (U.S. NIH Grant/Contract)
- E-E1A00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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