DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Refractory Multiple Myeloma

Intervention: liposomal doxorubicin (Drug); bortezomib (Drug); dexamethasone (Drug); cyclophosphamide (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Shaji Kumar, M.D., Study Chair, Affiliation: Mayo Clinic

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.

Clinical Details

Official title: A Phase II Study of Bortezomib, Liposomal Doxorubicin, Dexamethasone, and Cyclophosphamide in Patients With Multiple Myeloma Relapsing Within 12 Months of Autologous Stem Cell Transplant

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: One-year Survival in Patients Treated With This Regimen.

Detailed 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Colorado Cancer Research Program CCOP, Denver, Colorado 80224-2522, United States

Exempla Saint Joseph Hospital, Denver, Colorado 80218, United States

Porter Adventist Hospital, Denver, Colorado 80210, United States

Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado 80218, United States

Rose Medical Center, Denver, Colorado 80220, 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

Illinois CancerCare-Peoria, Peoria, Illinois 61615, United States

Illinois Oncology Research Association CCOP, Peoria, Illinois 61615, United States

Methodist Medical Center of Illinois, Peoria, Illinois 61603, United States

OSF Saint Francis Medical Center, Peoria, Illinois 61637, United States

Proctor Hospital, Peoria, Illinois 61614, 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 Lutheran Hospital, Des Moines, Iowa 50316, 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

Mercy Medical Center - North Iowa, Mason City, Iowa 50401, 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

Siouxland Hematology Oncology Associates, Sioux City, Iowa 51101, 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 - Main Office, Wichita, Kansas 67214, United States

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas 67208, 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

Mercy Saint Anne Hospital, Toledo, Ohio 43623, United States

Saint Vincent Mercy Medical Center, Toledo, Ohio 43608, United States

The Toledo Hospital/Toledo Children's Hospital, Toledo, Ohio 43606, United States

Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio 43623, United States

Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio 43617, United States

University of Toledo, Toledo, Ohio 43614, United States

Fulton County Health Center, Wauseon, Ohio 43567, United States

Butler Memorial Hospital, Butler, Pennsylvania 16001, United States

Geisinger Medical Center, Danville, Pennsylvania 17822-2001, 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

Additional Information

Starting date: September 2010
Last updated: January 5, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017