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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT00060346

Recruitment Status:

Terminated

Sponsor:

Eastern Cooperative Oncology Group

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There are 122 Locations for this study

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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove Indiana, 46107, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
William N. Wishard Memorial Hospital
Indianapolis Indiana, 46202, United States
Howard Community Hospital
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
Reid Hospital & Health Care Services, Incorporated
Richmond Indiana, 47374, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend Indiana, 46617, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport Iowa, 52803, United States
Genesis Medical Center - West Campus
Davenport Iowa, 52804, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center
Des Moines Iowa, 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City Iowa, 50401, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines Iowa, 50266, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina Kansas, 67401, United States
Cotton-O'Neil Cancer Center
Topeka Kansas, 66604, United States
St. Francis Comprehensive Cancer Center
Topeka Kansas, 66606, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Union Hospital Cancer Program at Union Hospital
Elkton Maryland, 21921, United States
Battle Creek Health System Cancer Care Center
Battle Creek Michigan, 49017, United States
Mecosta County Medical Center
Big Rapids Michigan, 49307, United States
CCOP - Grand Rapids
Grand Rapids Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids Michigan, 49503, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids Michigan, 49503, United States
Metro Health Hospital
Grand Rapids Michigan, 49506, United States
Holland Community Hospital
Holland Michigan, 49423, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Hackley Hospital
Muskegon Michigan, 49442, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph Michigan, 49085, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
MeritCare Bemidji
Bemidji Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield Minnesota, 55355, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul Minnesota, 55101, United States
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul Minnesota, 55102, United States
United Hospital
Saint Paul Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee Minnesota, 55379, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury Minnesota, 55125, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury Minnesota, 55125, United States
Saint Louis University Cancer Center
Saint Louis Missouri, 63110, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings Montana, 59101, United States
Billings Clinic Cancer Center
Billings Montana, 59107, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
St. James Healthcare Cancer Care
Butte Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls Montana, 59405, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington New Jersey, 08822, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton New Jersey, 08053, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees New Jersey, 08043, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx New York, 10466, United States
Interlakes Oncology/Hematology PC
Rochester New York, 14623, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro North Carolina, 27534, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Wilson Medical Center
Wilson North Carolina, 27893, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
MeritCare Broadway
Fargo North Dakota, 58122, United States
Aultman Cancer Center at Aultman Hospital
Canton Ohio, 44710, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital
Dayton Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence Ohio, 44131, United States
Charles F. Kettering Memorial Hospital
Kettering Ohio, 45429, United States
St. Rita's Medical Center
Lima Ohio, 45801, United States
Middletown Regional Hospital
Middletown Ohio, 45044, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy Ohio, 45373, United States
Cleveland Clinic - Wooster
Wooster Ohio, 44691, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia Ohio, 45385, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Lewistown Hospital
Lewistown Pennsylvania, 17044, United States
Geisinger Medical Group - Scenery Park
State College Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College Pennsylvania, 16803, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
AnMed Cancer Center
Anderson South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
Wilford Hall Medical Center
Lackland Air Force Base Texas, 78236, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT00060346

Recruitment Status:

Terminated

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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