Multiple Myeloma Clinical Trial
Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
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.
Full 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.
Eligibility 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)
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There are 74 Locations for this study
Scottsdale Arizona, 85259, United States
Duarte California, 91010, United States
Palo Alto California, 94304, United States
Stanford California, 94305, United States
Denver Colorado, 80224, United States
Wilmington Delaware, 19899, United States
Washington District of Columbia, 20060, United States
Gainesville Florida, 32608, United States
Gainesville Florida, 32610, United States
Miami Florida, 33125, United States
Tampa Florida, 33612, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Decatur Georgia, 30033, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Decatur Illinois, 62526, United States
Evanston Illinois, 60201, United States
Peoria Illinois, 61602, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
South Bend Indiana, 46601, United States
Bettendorf Iowa, 52722, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50309, United States
Iowa City Iowa, 52242, United States
Wichita Kansas, 67218, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48106, United States
Kalamazoo Michigan, 49007, United States
Duluth Minnesota, 55805, United States
Minneapolis Minnesota, 55417, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Omaha Nebraska, 68105, United States
Omaha Nebraska, 68106, United States
Las Vegas Nevada, 89106, United States
East Orange New Jersey, 07019, United States
Hackensack New Jersey, 07601, United States
New Brunswick New Jersey, 08903, United States
Bronx New York, 10461, United States
Bronx New York, 10466, United States
Brooklyn New York, 11209, United States
New York New York, 10010, United States
New York New York, 10016, United States
Rochester New York, 14642, United States
Fargo North Dakota, 58122, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Toledo Ohio, 43623, United States
Tulsa Oklahoma, 74136, United States
Danville Pennsylvania, 17822, United States
Philadelphia Pennsylvania, 19102, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15240, United States
Wynnewood Pennsylvania, 19096, United States
Sioux Falls South Dakota, 57104, United States
Nashville Tennessee, 37212, United States
Nashville Tennessee, 37232, United States
Temple Texas, 76508, United States
Green Bay Wisconsin, 54301, United States
Madison Wisconsin, 53705, United States
Madison Wisconsin, 53792, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
San Juan , 00927, Puerto Rico
San Juan , 00927, Puerto Rico
Pretoria , 0001, South Africa
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