Multiple Myeloma Clinical Trial
Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant
Summary
This phase II trial is studying how well giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide works in treating patients with multiple myeloma that relapsed after autologous stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide may kill more cancer cells.
Full Description
PRIMARY OBJECTIVES:
I. To evaluate the 1-year survival of patients with relapsed multiple myeloma treated with bortezomib, liposomal doxorubicin, dexamethasone, and cyclophosphamide.
SECONDARY OBJECTIVES:
I. To evaluate response rates in patients treated with this regimen.
II. To evaluate the median time to progression in patients treated with this regimen.
III. To evaluate the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Peripheral blood and bone marrow samples may be collected for future research. Patients complete the Functional Assessment of Cancer Therapy (FACT) neurotoxicity questionnaire periodically.
After completion of study treatment, patients are followed up every 3 months for 3 years.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of multiple myeloma that was symptomatic at the time of initial diagnosis
Must have met the following criteria at one point during the disease course:
Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytoma
Symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis, including at least 1 of the following:
Anemia
Hypercalcemia
Bone disease (lytic bone lesions or pathologic fracture)
Renal dysfunction
Disease relapsed < 12 months after autologous stem cell transplantation (SCT)
Measurable disease, as defined by the presence of ≥ 1 of the following:
Serum M-spike ≥ 1 g/dL
Urine M-spike ≥ 200 mg/24 hours
Involved free light chain (FLC) ≥ 10 mg/dL (provided the serum FLC is abnormal)
Plasma cells ≥ 30%
ECOG performance status 0-2
Negative pregnancy test
Fertile patients must use effective contraception
At least 14 days since prior palliative and/or localized radiotherapy
Left ventricular ejection fraction (LVEF) normal by Echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan
Hemoglobin > 8 g/dL
Platelet count ≥ 75,000/mm^3 (without transfusion support)
Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (without use of growth factors)
Creatinine < 2.5 mg/dL
Direct bilirubin ≤ 1.5 mg/dL
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal
All tests below must be performed within 14 days prior to registration:
Serum free light chain assay
Kappa free light chain
Lambda free light chain
Prior malignancy allowed provided it was treated curatively and has not relapsed in 5 years
Patients with basal cell skin cancer, in situ cervical cancer, or prostate cancer not requiring therapy are eligible
Exclusion Criteria:
Therapy for relapsed disease following SCT
Known allergy to bortezomib or anthracyclines
Prior allogeneic SCT
Peripheral neuropathy ≥ grade 2 according to the Cancer Therapy Evaluation Program (CTEP) active version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)
Concurrent uncontrolled illness that would limit study compliance, including the following:
Uncontrolled hypertension
Symptomatic congestive heart failure
Unstable angina
Uncontrolled cardiac arrhythmia
Uncontrolled psychiatric illness or social situation
Active uncontrolled infection
Prior doxorubicin hydrochloride exposure > 240 mg/m^2
Active, uncontrolled seizure disorder
Seizures within the past 6 months
Pregnant or nursing
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There are 113 Locations for this study
Scottsdale Arizona, 85259, United States
Aurora Colorado, 80012, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80907, United States
Denver Colorado, 80210, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Denver Colorado, 80224, United States
Englewood Colorado, 80113, United States
Grand Junction Colorado, 81502, United States
Greeley Colorado, 80631, United States
Lakewood Colorado, 80228, United States
Littleton Colorado, 80122, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80501, United States
Loveland Colorado, 80539, United States
Parker Colorado, 80138, United States
Pueblo Colorado, 81004, United States
Thornton Colorado, 80229, United States
Wheat Ridge Colorado, 80033, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19718, United States
Macon Georgia, 31208, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Macomb Illinois, 61455, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61603, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Clive Iowa, 50325, 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
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67901, United States
McPherson Kansas, 67460, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, 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 MD Maryland, 21921, United States
Boston Massachusetts, 02215, United States
Adrian Michigan, 49221, United States
Adrian Michigan, 49221, United States
Monroe Michigan, 48162, United States
Monroe Michigan, 48162, 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
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
New Ulm Minnesota, 56073, 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
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Camden New Jersey, 08103, United States
Bowling Green Ohio, 43402, United States
Cincinnati Ohio, 45236, United States
Cleveland Ohio, 44109, United States
Clyde Ohio, 43410, United States
Elyria Ohio, 44035, United States
Elyria Ohio, 44035, United States
Lima Ohio, 45804, United States
Maumee Ohio, 43537, United States
Norwalk Ohio, 44857, United States
Oregon Ohio, 43616, United States
Oregon Ohio, 43616, United States
Sandusky Ohio, 44870, United States
Sylvania Ohio, 43560, United States
Tiffin Ohio, 44883, United States
Toledo Ohio, 43606, United States
Toledo Ohio, 43608, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43617, United States
Toledo Ohio, 43623, United States
Toledo Ohio, 43623, United States
Wauseon Ohio, 43567, United States
Butler Pennsylvania, 16001, United States
Danville Pennsylvania, 17822, United States
Hazleton Pennsylvania, 18201, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Fredericksburg Virginia, 22401, United States
Johnson Creek Wisconsin, 53038, United States
Madison Wisconsin, 53792, United States
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