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.

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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.

View Eligibility Criteria

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)

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Study ID:

NCT00033332

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 74 Locations for this study

See Locations Near You

CCOP - Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto California, 94304, United States
Stanford University Medical Center
Stanford California, 94305, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver Colorado, 80224, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
MBCCOP - Howard University Cancer Center
Washington District of Columbia, 20060, United States
Veterans Affairs Medical Center - Gainesville
Gainesville Florida, 32608, United States
UF Shands Cancer Center
Gainesville Florida, 32610, United States
Veterans Affairs Medical Center - Miami
Miami Florida, 33125, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa Florida, 33612, United States
Emory University Hospital - Atlanta
Atlanta Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis Indiana, 46202, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf Iowa, 52722, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas, 67218, United States
MBCCOP - LSU Medical Center
New Orleans Louisiana, 70112, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Tuft-New England Medical Center
Boston Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Veterans Affairs Medical Center - Omaha
Omaha Nebraska, 68105, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07019, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Albert Einstein Clinical Cancer Center
Bronx New York, 10461, United States
MBCCOP-Our Lady of Mercy Cancer Center
Bronx New York, 10466, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn New York, 11209, United States
Veterans Affairs Medical Center - New York
New York New York, 10010, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
James P. Wilmot Cancer Center
Rochester New York, 14642, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
CCOP - Toledo Community Hospital
Toledo Ohio, 43623, United States
CCOP - Oklahoma
Tulsa Oklahoma, 74136, United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania, 17822, United States
Hahnemann University Hospital
Philadelphia Pennsylvania, 19102, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15213, United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh Pennsylvania, 15240, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57104, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay Wisconsin, 54301, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee Wisconsin, 53295, United States
MBCCOP - San Juan
San Juan , 00927, Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan , 00927, Puerto Rico
Pretoria Academic Hospitals
Pretoria , 0001, South Africa

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Study ID:

NCT00033332

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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