Multiple Myeloma Clinical Trial
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom’s Macroglobulinemia
Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed Waldenstrom's macroglobulinemia.
Full Description
OBJECTIVES:
Determine the response rate of patients with newly diagnosed Waldenstrom's macroglobulinemia treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
Determine the associated toxic effects of this regimen, specifically the frequency of febrile neutropenia, in these patients.
Determine the progression-free survival of patients treated with this regimen.
Correlate baseline cytogenetic features and gene expression profiles with response in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter study.
Patients receive rituximab intravenously (IV) over approximately 4 hours, cyclophosphamide IV over 5-30 minutes, doxorubicin IV over 5-15 minutes, and vincristine IV over 1 minute on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
ACTUAL ACCRUAL: A total of 16 patients were accrued for this study.
Eligibility Criteria
INCLUSION CRITERIA:
Diagnosis of Waldenstrom's macroglobulinemia confirmed by the presence of the following:
Bone marrow lymphoplasmacytosis with: > 10% lymphoplasmacytic cells OR aggregates or sheets of one of the following: lymphocytes, plasma cells or lymphoplasmacytic cells on the bone marrow biopsy (measured within 4 weeks prior to registration)
Measurable disease defined as a quantitative immunoglobulin M (IgM) monoclonal protein of > 1,000 mg/dL obtained within 4 weeks prior to registration
Cluster of differentiation 20 (CD20) positive stain of bone marrow or lymph node samples obtained < 8 weeks prior to registration
Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma, defined by 1 of the following:
Hemoglobin no greater than 11 g/dL
Serum viscosity level relative to water of at least 4.0 centipoise
Absolute neutrophil count at least 1,000/mm^3
Platelet count at least 75,000/mm^3
Bilirubin no greater than 3.0 mg/dL
Aspartate aminotransferase (AST) no greater than 3 times upper limit of normal
Creatinine no greater than 3.0 mg/dL
Age of 18 and over
ECOG (Eastern Cooperative Oncology Group) performance status 0-1
Must be symptomatic with 1 of the following:
Clinically significant anemia (hemoglobin no greater than 11 g/dL)
Bulky lymphadenopathy
Symptoms attributable to hyperviscosity (e.g., nose bleeding, gingival bleeding, or retinal hemorrhage)
History of heart disease allowed only if 1 of the following is demonstrated by echocardiography, multigated acquisition scan (MUGA), exercise MUGA, or coronary catheterization:
Ejection fraction of at least 45%
Normal fractional shortening of the left ventricle
Must have been tested for hepatitis B surface antigen within 2 weeks of registration
Negative pregnancy test
Fertile patients must use effective contraception
EXCLUSION CRITERIA:
Prior treatment for Waldenstrom's macroglobulinemia
Prior anti-CD20 therapy
Concurrent steroids exceeding 10 mg prednisone (or equivalent) per day
Prior irradiation if less than 4 weeks had elapsed prior to registration and the date of last treatment
Prior anthracyclines
Prior malignancy except curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer curatively treated with surgery alone and from which patient has been disease free for at least 5 years
Active heart disease
Pregnant or nursing
Myocardial infarction within the past 3 months
Congestive heart failure
Symptomatic ventricular arrhythmia
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There are 122 Locations for this study
Little Rock Arkansas, 72205, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Aurora Illinois, 60507, United States
Joliet Illinois, 60435, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Beech Grove Indiana, 46107, United States
Elkhart Indiana, 46515, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Michigan City Indiana, 46360, United States
Richmond Indiana, 47374, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
Ames Iowa, 50010, United States
Davenport Iowa, 52803, United States
Davenport Iowa, 52804, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Mason City Iowa, 50401, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
West Des Moines Iowa, 50266, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Salina Kansas, 67401, United States
Topeka Kansas, 66604, United States
Topeka Kansas, 66606, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Elkton Maryland, 21921, United States
Battle Creek Michigan, 49017, United States
Big Rapids Michigan, 49307, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49506, United States
Holland Michigan, 49423, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Muskegon Michigan, 49442, United States
Saint Joseph Michigan, 49085, United States
Traverse City Michigan, 49684, United States
Bemidji Minnesota, 56601, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Litchfield Minnesota, 55355, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Waconia Minnesota, 55387, United States
Woodbury Minnesota, 55125, United States
Woodbury Minnesota, 55125, United States
Saint Louis Missouri, 63110, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Flemington New Jersey, 08822, United States
Marlton New Jersey, 08053, United States
Voorhees New Jersey, 08043, United States
Voorhees New Jersey, 08043, United States
Bronx New York, 10466, United States
Rochester New York, 14623, United States
Rochester New York, 14642, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Rutherfordton North Carolina, 28139, United States
Wilson North Carolina, 27893, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Canton Ohio, 44710, United States
Cleveland Ohio, 44195, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Independence Ohio, 44131, United States
Kettering Ohio, 45429, United States
Lima Ohio, 45801, United States
Middletown Ohio, 45044, United States
Troy Ohio, 45373, United States
Wooster Ohio, 44691, United States
Xenia Ohio, 45385, United States
Danville Pennsylvania, 17822, United States
Hershey Pennsylvania, 17033, United States
Lewistown Pennsylvania, 17044, United States
State College Pennsylvania, 16801, United States
State College Pennsylvania, 16803, United States
Wilkes-Barre Pennsylvania, 18711, United States
Anderson South Carolina, 29621, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Fort Sam Houston Texas, 78234, United States
Lackland Air Force Base Texas, 78236, United States
Temple Texas, 76508, United States
Danville Virginia, 24541, United States
La Crosse Wisconsin, 54601, United States
Sheridan Wyoming, 82801, United States
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