S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma
NCT ID: NCT01903811
Last Updated: 2024-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2013-10-31
2019-03-07
Brief Summary
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Detailed Description
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I. To evaluate and compare progression free survival (PFS) of two different doses of carfilzomib with dexamethasone in multiple myeloma (MM) patients with relapsed and/or refractory disease.
SECONDARY OBJECTIVES:
I. To evaluate and compare response rates (RR) for each arm. II. To evaluate response rates (RR) for patients that relapse on low dose carfilzomib and subsequently cross-over to high dose carfilzomib.
III. To evaluate the safety of this combination for this patient population. IV. To evaluate overall survival (OS).
TERTIARY OBJECTIVES:
I. To explore the molecular variability in MM cells obtained from extramedullary bone marrow relapse sites.
II. To explore the role of positron emission tomography (PET) scanning in assessing disease burden and as a tool to assess treatment response.
III. To explore changes in left ventricular ejection fraction (LVEF) in patients with relapsed or refractory multiple myeloma treated with low dose carfilzomib or high dose carfilzomib plus dexamethasone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive dexamethasone intravenously (IV) and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. Patients with progression cross-over to Arm II.
ARM II: Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16.
Note that for the first course of treatment on both arms carfilzomib is given at a reduced rate to assess toxicity.
In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years from initial registration.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm I (dexamethasone, low-dose carfilzomib)
Patients receive dexamethasone IV and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with progression cross-over to Arm II.
Carfilzomib
Given IV
Dexamethasone
Given IV
Laboratory Biomarker Analysis
Correlative studies
Arm II (dexamethasone, high-dose carfilzomib)
Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose over 2-10 minutes.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Carfilzomib
Given IV
Dexamethasone
Given IV
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Carfilzomib
Given IV
Dexamethasone
Given IV
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have a confirmed diagnosis of symptomatic multiple myeloma and must be currently relapsed or refractory; all tests for establishing disease status must be completed within 28 days prior to registration and documented on the Baseline Tumor Assessment Form for Multiple Myeloma
* Patients must have measurable disease within 28 days prior to registration
* Patients must have received at least one prior regimen of chemotherapy for symptomatic multiple myeloma; patients may not have more than six (6) previous regimens of therapy for the disease; prior chemotherapy must have been completed at least 21 days prior to registration; for study purposes, a regimen is defined as follows:
* An anti-myeloma therapy used at the time of initial diagnosis or documented disease progression which is given with the intent to decrease disease burden
* Any maintenance therapy used after an Induction should be considered part of that Induction regimen
* Use of any agent or combination of agents more than once during the patient's disease history for separate documented disease progressions will be counted as separate regimens (e.g., if a patient receives lenalidomide/bortezomib at initial diagnosis and achieves response, but then progresses and receives lenalidomide/bortezomib after progression, these count as 2 separate regimens)
* In cases of allogeneic or autologous stem cell transplant, the entire induction + stem cell mobilization + conditioning + planned maintenance should be considered one regimen
* Patients may not have received any prior carfilzomib treatment
* Patients must not be receiving any other concurrent therapy considered to be investigational; patients must not be planning to receive any radiotherapy (except localized radiation for palliative care); patients must not be planning to receive any concurrent chemotherapy, immunotherapy, radiotherapy or other treatment with curative intent
* Patients must have complete history and physical examination within 28 days prior to registration
* Patients must have baseline PET scan within 28 days prior to registration; note that images are submitted centrally for review
* Patients with non-secretory MM or known primary amyloidosis are not eligible
* Patients must have Zubrod performance status 0-2
* Patients must not have clinically significant illness including uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or \>= grade 3 cardiac arrhythmias
* Patients must have undergone an electrocardiogram (EKG) within 28 days prior to registration
* Patients must have either echocardiogram (ECHO) with ejection fraction \>= 45% within 28 days prior to registration
* Patients must not have \> grade 2 neuropathy and/or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\< 3 x ULN
* Absolute neutrophil count (ANC) \>= 1,000 cell/mm\^3 without growth factor support within 14 days prior to registration
* Platelets \>= 50,000 cells/mm\^3 for patients who have bone marrow plasmacytosis \< 50% or \>= 30,000 cells/mm\^3 for patients who have bone marrow plasmacytosis of \>= 50% within 14 days prior to registration
* Calculated or measured creatinine clearance \>= 30 ml/min within 14 days prior to registration
* Patients who are known to be human immunodeficiency virus positive (HIV+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration:
* Cluster of differentiation (CD)4 cells \>= 500/mm\^3
* Viral load of \< 50 copies HIV messenger ribonucleic acid (mRNA)/mm\^3 if on combination antiretroviral therapy (cART) or \< 25,000 copies HIV mRNA if not on cART
* No zidovudine or stavudine as part of cART
* Patients who are HIV+ and do not meet all of these criteria are not eligible for this study
* Patients with known hepatitis B or hepatitis C infection must have viral load \< 800,000 IU/L within 28 days prior to registration
* Patients must have baseline skeletal survey to document lytic lesions, osteopenia or compression fracture within 28 days prior to registration
* Patients may have received palliative external beam radiation therapy (XRT) for local disease control with no curative intent. XRT must be completed at least 7 days prior to registration
* Patients must be offered participation in specimen submission for translational medicine studies and banking; with patient consent, specimens must be submitted
* Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years
* Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* REGISTRATION STEP 2: CROSSOVER
* Patient must have been eligible for and initially randomized to Arm 1 (low dose carfilzomib), begun cycle 2 of treatment, and progressed prior to completing 12 cycles of protocol therapy
* At least 14 days and no more than 28 days must have elapsed between the last day of treatment on Arm 1 and registration to Arm 3
* Patients must have recovered from all non-hematologic toxicities to =\< grade 2 and from all hematologic toxicities to =\< grade 3 prior to registration
* Patients must have begun cycle 2 (carfilzomib - 27 mg/m\^2) and must not have received any dose reduction for toxicity in the last cycle of treatment, immediately preceding progression
* Patients must have serum protein electrophoresis (SPEP) and kappa and lambda light chain testing performed within 14 days prior to registration in order to establish baseline measurements
* Patients must not have ejection fraction decrease \> 10% from baseline (as determined by ECHO) or other ejection fraction decrease accompanied by other clinical signs/symptoms of New York Heart Association (NYHA) class III or IV heart failure, measured within 28 days prior to registration; if any question exists regarding individual patient eligibility in this situation, contact the study chair for determination
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Sikander Ailawadhi
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States
Kaiser Permanente-Bellflower
Bellflower, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Mills - Peninsula Hospitals
Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
John Muir Medical Center-Concord Campus
Concord, California, United States
Sutter Davis Hospital
Davis, California, United States
Kaiser Permanente Hospital
Fontana, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Kaiser Permanente
Fresno, California, United States
Kaiser Permanente - Harbor City
Harbor City, California, United States
Kaiser Permanente-Irvine
Irvine, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Kaiser Permanente-Cadillac
Los Angeles, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
Memorial Medical Center
Modesto, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Kaiser Permanente - Panorama City
Panorama City, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Kaiser Permanente-Riverside
Riverside, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter General Hospital
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente - Sacramento
Sacramento, California, United States
Kaiser Permanente-San Diego Mission
San Diego, California, United States
Kaiser Permanente-San Diego Zion
San Diego, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Marcos
San Marcos, California, United States
Kaiser Permanente-San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Stockton
Stockton, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
Kaiser Permanente
Woodland Hills, California, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Medical Oncology and Hematology Group PC-Guilford
Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Smilow Cancer Hospital-Orange Care Center
Orange, Connecticut, United States
Charlotte Hungerford Hospital Center for Cancer Care
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Regional Hematology and Oncology PA
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Nanticoke Memorial Hospital
Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Florida Hospital Orlando
Orlando, Florida, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, United States
Kuakini Medical Center
Honolulu, Hawaii, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States
Castle Medical Center
Kailua, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Hawaii Oncology Inc-Pali Momi
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Kootenai Cancer Clinic
Sandpoint, Idaho, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Carle on Vermilion
Danville, Illinois, United States
Cancer Care Center of Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States
Spector, David MD (UIA Investigator)
Moline, Illinois, United States
Trinity Medical Center
Moline, Illinois, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Community Cancer Center Foundation
Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Radiation Oncology of Northern Illinois
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
The Carle Foundation Hospital
Urbana, Illinois, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States
Woodland Cancer Care Center
Michigan City, Indiana, United States
Reid Health
Richmond, Indiana, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States
Hematology Oncology Associates-Quad Cities
Bettendorf, Iowa, United States
McFarland Clinic PC-Boone
Boone, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, United States
Genesis Medical Center - East Campus
Davenport, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa, United States
McFarland Clinic PC-Jefferson
Jefferson, Iowa, United States
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Methodist West Hospital
West Des Moines, Iowa, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States
Hematology/Oncology Clinic LLP
Baton Rouge, Louisiana, United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Medical Oncology LLC
Baton Rouge, Louisiana, United States
Mary Bird Cancer Center/Saint Tammany Parish
Covington, Louisiana, United States
Mary Bird Perkins Cancer Center/Terrebonne General Medical Center
Houma, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Central Maine Medical Center
Lewiston, Maine, United States
Penobscot Bay Medical Center
Rockport, Maine, United States
Peninsula Regional Medical Center
Salisbury, Maryland, United States
Beverly Hospital
Beverly, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, United States
Bixby Medical Center
Adrian, Michigan, United States
Hickman Cancer Center
Adrian, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Memorial Hospital
Monroe, Michigan, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Lake Huron Medical Center
Port Huron, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Providence Hospital-Southfield Cancer Center
Southfield, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States
CoxHealth Cancer Center
Branson, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Saint Luke's Hospital
Chesterfield, Missouri, United States
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Montana Cancer Consortium NCORP
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States
21st Century Oncology - Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States
21st Century Oncology
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, United States
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States
21st Century Oncology - Fort Apache
Las Vegas, Nevada, United States
Cancer and Blood Specialists-Fort Apache
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
21st Century Oncology - Vegas Tenaya
Las Vegas, Nevada, United States
Inspira Medical Center Vineland
Vineland, New Jersey, United States
Inspira Medical Center Woodbury
Woodbury, New Jersey, United States
Orange Regional Medical Center
Middletown, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Hendersonville Hematology and Oncology at Pardee
Hendersonville, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Kinston Medical Specialists PA
Kinston, North Carolina, United States
Cone Heath Cancer Center at Mebane
Mebane, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Southeastern Medical Oncology Center-Wilson
Wilson, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Roger Maris Cancer Center
Fargo, North Dakota, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
Aultman Health Foundation
Canton, Ohio, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, United States
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, United States
Mount Carmel East Hospital
Columbus, Ohio, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Health Center
Dayton, Ohio, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States
Delaware Radiation Oncology
Delaware, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Lancaster Radiation Oncology
Lancaster, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
OneHealth Marion General Hospital
Marion, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Newark Radiation Oncology
Newark, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
Springfield Regional Cancer Center
Springfield, Ohio, United States
Springfield Regional Medical Center
Springfield, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
Riddle Memorial Hospital
Media, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, United States
Penn State Health Saint Joseph Medical Center
Reading, Pennsylvania, United States
Grand View Hospital
Sellersville, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
M D Anderson Cancer Center
Houston, Texas, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Pacific Medical Center-First Hill
Seattle, Washington, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, United States
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Mercy Health System
Janesville, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States
Saint Mary's Hospital
Rhinelander, Wisconsin, United States
Lakeview Medical Center-Marshfield Clinic
Rice Lake, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Saint Clare's Hospital
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Big Horn Basin Cancer Center
Cody, Wyoming, United States
Billings Clinic-Cody
Cody, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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References
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Ailawadhi S, Sexton R, Lentzsch S, Abidi MH, Voorhees PM, Cohen AD, Rohren EM, Heitner S, Kelly K, Mackler NJ, Baer DM, Hoering A, Durie B, Orlowski RZ. Low-dose versus High-dose Carfilzomib with Dexamethasone (S1304) in Patients with Relapsed-Refractory Multiple Myeloma. Clin Cancer Res. 2020 Aug 1;26(15):3969-3978. doi: 10.1158/1078-0432.CCR-19-1997. Epub 2020 Apr 16.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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NCI-2013-00796
Identifier Type: REGISTRY
Identifier Source: secondary_id
PS1304_A07PAMDREVW01
Identifier Type: -
Identifier Source: secondary_id
SWOG-S1304
Identifier Type: -
Identifier Source: secondary_id
S1304
Identifier Type: OTHER
Identifier Source: secondary_id
S1304
Identifier Type: OTHER
Identifier Source: secondary_id
S1304
Identifier Type: -
Identifier Source: org_study_id