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Home > "D" Clinical Trials Conditions > Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma



Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

For Condition: stage 2 multiple myeloma,stage 3 multiple myeloma,stage 1 multiple myeloma
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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)
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
S.Rajkumar,  Study Chair,  Mayo Clinic Cancer Center

Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee,  Wisconsin,  53295
United States
 

Pretoria Academic Hospitals
Pretoria,  ,  0001
South Africa
 

UF Shands Cancer Center
Gainesville,  Florida,  32610-0277
United States
 

Veterans Affairs Medical Center - Madison
Madison,  Wisconsin,  53705-2286
United States
 

Veterans Affairs Medical Center - Omaha
Omaha,  Nebraska,  68105
United States
 

Veterans Affairs Medical Center - Wichita
Wichita,  Kansas,  67218
United States
 

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City,  New York,  10016
United States
 

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

Vanderbilt-Ingram Cancer Center
Nashville,  Tennessee,  37232-6307
United States
 

CCOP - Oklahoma
Tulsa,  Oklahoma,  74136
United States
 

Albert Einstein Clinical Cancer Center
Bronx,  New York,  10461
United States
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5289
United States
 

Veterans Affairs Medical Center - Pittsburgh
Pittsburgh,  Pennsylvania,  15240-0001
United States
 

Veterans Affairs Medical Center - Miami
Miami,  Florida,  33125
United States
 

CCOP - Southern Nevada Cancer Research Foundation
Las Vegas,  Nevada,  89106
United States
 

CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay,  Wisconsin,  54301
United States
 

University of Pittsburgh Cancer Institute
Pittsburgh,  Pennsylvania,  15213-3489
United States
 

Holden Comprehensive Cancer Center
Iowa City,  Iowa,  52242-1009
United States
 

CCOP - Toledo Community Hospital
Toledo,  Ohio,  43623-3456
United States
 

Cancer Institute of New Jersey
New Brunswick,  New Jersey,  08903
United States
 

CCOP - Scottsdale Oncology Program
Scottsdale,  Arizona,  85259-5404
United States
 

Veterans Affairs Medical Center - Brooklyn
Brooklyn,  New York,  11209
United States
 

Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis,  Indiana,  46202
United States
 

CCOP - Ann Arbor Regional
Ann Arbor,  Michigan,  48106
United States
 

City of Hope Comprehensive Cancer Center
Duarte,  California,  91010-3000
United States
 

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195
United States
 

CCOP - Evanston
Evanston,  Illinois,  60201
United States
 

University of Pennsylvania Cancer Center
Philadelphia,  Pennsylvania,  19104
United States
 

CCOP - Cedar Rapids Oncology Project
Cedar Rapids,  Iowa,  52403-1206
United States
 

Veterans Affairs Medical Center - East Orange
East Orange,  New Jersey,  07019
United States
 

CCOP - Scott and White Hospital
Temple,  Texas,  76508
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

MBCCOP-Our Lady of Mercy Cancer Center
Bronx,  New York,  10466
United States
 

Veterans Affairs Medical Center - Gainesville
Gainesville,  Florida,  32608-1197
United States
 

CCOP - Merit Care Hospital
Fargo,  North Dakota,  58122
United States
 

Tuft-New England Medical Center
Boston,  Massachusetts,  02111
United States
 

Emory University Hospital - Atlanta
Atlanta,  Georgia,  30322
United States
 

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611-3013
United States
 

CCOP - Colorado Cancer Research Program, Inc.
Denver,  Colorado,  80224
United States
 

CCOP - MainLine Health
Wynnewood,  Pennsylvania,  19096
United States
 

CCOP - Duluth
Duluth,  Minnesota,  55805
United States
 

CCOP - Kalamazoo
Kalamazoo,  Michigan,  49007-3731
United States
 

CCOP - Metro-Minnesota
St. Louis Park,  Minnesota,  55416
United States
 

Medical College of Wisconsin
Milwaukee,  Wisconsin,  53226-3596
United States
 

Stanford University Medical Center
Stanford,  California,  94305-5408
United States
 

CCOP - Northern New Jersey
Hackensack,  New Jersey,  07601
United States
 

CCOP - Sioux Community Cancer Consortium
Sioux Falls,  South Dakota,  57104
United States
 

Veterans Affairs Medical Center - Palo Alto
Palo Alto,  California,  94304-1290
United States
 

Fox Chase Cancer Center
Philadelphia,  Pennsylvania,  19111
United States
 

CCOP - Marshfield Medical Research and Education Foundation
Marshfield,  Wisconsin,  54449
United States
 

CCOP - Missouri Valley Cancer Consortium
Omaha,  Nebraska,  68106
United States
 

CCOP - Northern Indiana CR Consortium
South Bend,  Indiana,  46601
United States
 

MBCCOP - LSU Medical Center
New Orleans,  Louisiana,  70112
United States
 

Veterans Affairs Medical Center - San Juan
San Juan,  ,  00927-5800
Puerto Rico
 

CCOP - Ochsner
New Orleans,  Louisiana,  70121
United States
 

CCOP - Christiana Care Health Services
Wilmington,  Delaware,  19899
United States
 

Veterans Affairs Medical Center - Lakeside Chicago
Chicago,  Illinois,  60611-4494
United States
 

CCOP - Iowa Oncology Research Association
Des Moines,  Iowa,  50309-1016
United States
 

Veterans Affairs Medical Center - New York
New York City,  New York,  10010
United States
 

MBCCOP - San Juan
San Juan,  ,  00927-5800
Puerto Rico
 

CCOP - Geisinger Clinic and Medical Center
Danville,  Pennsylvania,  17822-2001
United States
 

Beth Israel Deaconess Medical Center
Boston,  Massachusetts,  02215
United States
 

University of Minnesota Cancer Center
Minneapolis,  Minnesota,  55455
United States
 

Veterans Affairs Medical Center - Tampa (Haley)
Tampa,  Florida,  33612
United States
 

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville,  Tennessee,  37212-2637
United States
 

CCOP - Illinois Oncology Research Association
Peoria,  Illinois,  61602
United States
 

Mayo Clinic Cancer Center
Rochester,  Minnesota,  55905
United States
 

Hematology Oncology Associates of the Quad Cities
Bettendorf,  Iowa,  52722
United States
 

Veterans Affairs Medical Center - Minneapolis
Minneapolis,  Minnesota,  55417-2399
United States
 

Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur,  Georgia,  30033
United States
 

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore,  Maryland,  21231-2410
United States
 

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33612-9497
United States
 

Hahnemann University Hospital
Philadelphia,  Pennsylvania,  19102-1192
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 

University of Wisconsin Comprehensive Cancer Center
Madison,  Wisconsin,  53792-0001
United States
 

MBCCOP - Howard University Cancer Center
Washington D.C.,  District of Columbia,  20060
United States
 

CCOP - Carle Cancer Center
Urbana,  Illinois,  61801
United States
 

James P. Wilmot Cancer Center
Rochester,  New York,  14642
United States
 


Additional Information:
Study ID Numbers:
  CDR0000069274;  E-E1A00
Study Start Date: 
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033332

Other Stage 3 Multiple Myeloma Studies:
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2. Chemotherapy, Vaccine Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Multiple Myeloma

3. Rituximab in Treating Patients With Multiple Myeloma

4. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

5. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

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