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.

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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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

2

Study ID:

NCT01078441

Recruitment Status:

Terminated

Sponsor:

National Cancer Institute (NCI)

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There are 113 Locations for this study

See Locations Near You

Mayo Clinic in Arizona
Scottsdale Arizona, 85259, United States
The Medical Center of Aurora
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs Colorado, 80907, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Exempla Saint Joseph Hospital
Denver Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver Colorado, 80218, United States
Rose Medical Center
Denver Colorado, 80220, United States
Colorado Cancer Research Program CCOP
Denver Colorado, 80224, United States
Swedish Medical Center
Englewood Colorado, 80113, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction Colorado, 81502, United States
North Colorado Medical Center
Greeley Colorado, 80631, United States
Saint Anthony Hospital
Lakewood Colorado, 80228, United States
Littleton Adventist Hospital
Littleton Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Longmont United Hospital
Longmont Colorado, 80501, United States
McKee Medical Center
Loveland Colorado, 80539, United States
Parker Adventist Hospital
Parker Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge Colorado, 80033, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
Medical Center of Central Georgia
Macon Georgia, 31208, United States
Saint Joseph Medical Center
Bloomington Illinois, 61701, United States
Graham Hospital Association
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Eureka Hospital
Eureka Illinois, 61530, United States
Illinois CancerCare Galesburg
Galesburg Illinois, 61401, United States
Mason District Hospital
Havana Illinois, 62644, United States
Mcdonough District Hospital
Macomb Illinois, 61455, United States
Bromenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center Foundation
Normal Illinois, 61761, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa Illinois, 61350, United States
Pekin Cancer Treatment Center
Pekin Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61603, United States
Proctor Hospital
Peoria Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
Illinois Oncology Research Association CCOP
Peoria Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria Illinois, 61637, United States
Illinois Valley Hospital
Peru Illinois, 61354, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Iowa Oncology Research Association CCOP
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Mercy Medical Center - North Iowa
Mason City Iowa, 50401, United States
Siouxland Hematology Oncology Associates
Sioux City Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City Iowa, 51104, United States
Saint Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal Kansas, 67901, United States
Cancer Center of Kansas - McPherson
McPherson Kansas, 67460, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates In Womens Health
Wichita Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas - Main Office
Wichita Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Wichita CCOP
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
Union Hospital of Cecil County
Elkton MD Maryland, 21921, United States
Eastern Cooperative Oncology Group
Boston Massachusetts, 02215, United States
Bixby Medical Center
Adrian Michigan, 49221, United States
Hickman Cancer Center
Adrian Michigan, 49221, United States
Community Cancer Center of Monroe
Monroe Michigan, 48162, United States
Mercy Memorial Hospital
Monroe Michigan, 48162, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview-Southdale Hospital
Edina Minnesota, 55435, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
New Ulm Medical Center
New Ulm Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Metro-Minnesota CCOP
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee Minnesota, 55379, United States
Lakeview Hospital
Stillwater Minnesota, 55082, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States
Cooper Hospital University Medical Center
Camden New Jersey, 08103, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green Ohio, 43402, United States
The Jewish Hospital
Cincinnati Ohio, 45236, United States
MetroHealth Medical Center
Cleveland Ohio, 44109, United States
North Coast Cancer Care-Clyde
Clyde Ohio, 43410, United States
Community Health Partners Regional Medical Center
Elyria Ohio, 44035, United States
Hematology Oncology Center Incorporated
Elyria Ohio, 44035, United States
Lima Memorial Hospital
Lima Ohio, 45804, United States
Toledo Clinic Cancer Centers-Maumee
Maumee Ohio, 43537, United States
Fisher-Titus Medical Center
Norwalk Ohio, 44857, United States
Saint Charles Hospital
Oregon Ohio, 43616, United States
Toledo Clinic Cancer Centers-Oregon
Oregon Ohio, 43616, United States
North Coast Cancer Care
Sandusky Ohio, 44870, United States
Flower Hospital
Sylvania Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin Ohio, 44883, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo Ohio, 43606, United States
Saint Vincent Mercy Medical Center
Toledo Ohio, 43608, United States
University of Toledo
Toledo Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo Ohio, 43617, United States
Mercy Saint Anne Hospital
Toledo Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo Ohio, 43623, United States
Fulton County Health Center
Wauseon Ohio, 43567, United States
Butler Memorial Hospital
Butler Pennsylvania, 16001, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazelton
Hazleton Pennsylvania, 18201, United States
Geisinger Medical Group
State College Pennsylvania, 16801, United States
Geisinger Wyoming Valley
Wilkes-Barre Pennsylvania, 18711, United States
Fredericksburg Oncology Inc
Fredericksburg Virginia, 22401, United States
UW Cancer Center Johnson Creek
Johnson Creek Wisconsin, 53038, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

2

Study ID:

NCT01078441

Recruitment Status:

Terminated

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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