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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01903811
Other study ID # S1304
Secondary ID NCI-2013-00796PS
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2013
Est. completion date March 7, 2019

Study information

Verified date April 2020
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II trial compares how well two different doses of carfilzomib work when given with dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib together with dexamethasone may kill more cancer cells. It is not yet known whether a higher or lower dose of carfilzomib works better when given with dexamethasone.


Description:

PRIMARY OBJECTIVES:

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.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date March 7, 2019
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- REGISTRATION STEP 1: INITIAL RANDOMIZATION

- 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

Study Design


Intervention

Drug:
Carfilzomib
Given IV
Dexamethasone
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
United States Hawaii Oncology Inc-Pali Momi 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa
United States Kaiser Permanente-Anaheim Anaheim California
United States AnMed Health Cancer Center Anderson South Carolina
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States Randolph Hospital Asheboro North Carolina
United States Sutter Auburn Faith Hospital Auburn California
United States Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rush - Copley Medical Center Aurora Illinois
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Eastern Maine Medical Center Bangor Maine
United States Hematology/Oncology Clinic LLP Baton Rouge Louisiana
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Medical Oncology LLC Baton Rouge Louisiana
United States Kaiser Permanente-Bellflower Bellflower California
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Clinic North-Bemidgi Bemidji Minnesota
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa
United States Hematology Oncology Associates-Quad Cities Bettendorf Iowa
United States Beverly Hospital Beverly Massachusetts
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 Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
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 McFarland Clinic PC-Boone Boone Iowa
United States Boston Medical Center Boston Massachusetts
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Bozeman Deaconess Hospital Bozeman Montana
United States CoxHealth Cancer Center Branson Missouri
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Mills - Peninsula Hospitals Burlingame California
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Cone Health Cancer Center at Alamance Regional Burlington North Carolina
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Aultman Health Foundation Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Rocky Mountain Oncology Casper Wyoming
United States Eden Hospital Medical Center Castro Valley California
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Saint Luke's Hospital Chesterfield Missouri
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Oncology Hematology Care Inc - Anderson Cincinnati Ohio
United States Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio
United States Oncology Hematology Care Inc-Eden Park Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States Oncology Hematology Care Inc-Mercy West Cincinnati Ohio
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Big Horn Basin Cancer Center Cody Wyoming
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Medical Center Coeur d'Alene Idaho
United States Columbus NCI Community Oncology Research Program Columbus Ohio
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States John Muir Medical Center-Concord Campus Concord California
United States Mercy Hospital Coon Rapids Minnesota
United States Mary Bird Cancer Center/Saint Tammany Parish Covington Louisiana
United States Oncology Hematology Care Inc-Crestview Crestview Hills Kentucky
United States Carle on Vermilion Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Genesis Medical Center - East Campus Davenport Iowa
United States Sutter Davis Hospital Davis California
United States Dayton NCI Community Oncology Research Program Dayton 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 Beaumont Hospital-Dearborn Dearborn Michigan
United States Cancer Care Center of Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
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 Smilow Cancer Hospital-Derby Care Center Derby Connecticut
United States Iowa Lutheran Hospital Des Moines 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 Henry Ford Hospital Detroit Michigan
United States Saint John Hospital and Medical Center Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Sacred Heart Hospital Eau Claire Wisconsin
United States Fairview-Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Illinois CancerCare-Eureka Eureka Illinois
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Oncology Hematology Care Inc-Healthplex Fairfield Ohio
United States Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut
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 Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Blanchard Valley Hospital Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin
United States Kaiser Permanente Hospital Fontana California
United States McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Kaiser Permanente-Fremont Fremont California
United States Kaiser Permanente Fresno California
United States Unity Hospital Fridley Minnesota
United States University of Florida Gainesville Florida
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Green Bay Oncology at Saint Vincent Hospital 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 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Cone Health Cancer Center Greensboro North Carolina
United States Wayne Hospital Greenville Ohio
United States Medical Oncology and Hematology Group PC-Guilford Guilford Connecticut
United States Kaiser Permanente - Harbor City Harbor City California
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States 21st Century Oncology - Henderson Henderson Nevada
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Hendersonville Hematology and Oncology at Pardee Hendersonville North Carolina
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Hawaii Cancer Care Inc-POB II Honolulu Hawaii
United States Hawaii Oncology Inc-Kuakini Honolulu Hawaii
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Kuakini Medical Center 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 Mary Bird Perkins Cancer Center/Terrebonne General Medical Center Houma Louisiana
United States M D Anderson Cancer Center Houston Texas
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Kaiser Permanente-Irvine Irvine California
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Mayo Clinic in Florida Jacksonville Florida
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Mercy Health System Janesville Wisconsin
United States McFarland Clinic PC-Jefferson Jefferson Iowa
United States Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City Missouri
United States Freeman Health System Joplin Missouri
United States Castle Medical Center Kailua Hawaii
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Kinston Medical Specialists PA Kinston North Carolina
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster Radiation Oncology Lancaster Ohio
United States Sparrow Hospital Lansing Michigan
United States 21st Century Oncology Las Vegas Nevada
United States 21st Century Oncology - Fort Apache Las Vegas Nevada
United States 21st Century Oncology - Vegas Tenaya Las Vegas Nevada
United States Cancer and Blood Specialists-Fort Apache Las Vegas Nevada
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Cancer Therapy and Integrative Medicine Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills 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 HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center 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 Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Beebe Medical Center Lewes Delaware
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Central Maine Medical Center Lewiston Maine
United States Lewistown Hospital Lewistown Pennsylvania
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Lima Memorial Hospital Lima Ohio
United States Saint Mary Mercy Hospital Livonia Michigan
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente-Cadillac 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 Illinois CancerCare-Macomb Macomb Illinois
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Bay Area Medical Center Marinette Wisconsin
United States Vince Lombardi Cancer Clinic-Marinette Marinette Wisconsin
United States OneHealth Marion General Hospital Marion Ohio
United States McFarland Clinic PC-Marshalltown Marshalltown Iowa
United States Marshfield Clinic Marshfield Wisconsin
United States Saint Joseph's Hospital Marshfield Wisconsin
United States Fremont - Rideout Cancer Center Marysville California
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio
United States Loyola University Medical Center Maywood Illinois
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Cone Heath Cancer Center at Mebane Mebane North Carolina
United States Riddle Memorial Hospital Media Pennsylvania
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Woodland Cancer Care Center Michigan City Indiana
United States Orange Regional Medical Center Middletown New York
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 Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Hospital Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Kaiser Permanente-Modesto Modesto California
United States Memorial Medical Center Modesto California
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 Mercy Memorial Hospital Monroe Michigan
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States Yale University New Haven Connecticut
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Christiana Care Health System-Christiana Hospital Newark 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 Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Newark Radiation Oncology Newark Ohio
United States Regional Hematology and Oncology PA Newark Delaware
United States USC Norris Oncology/Hematology-Newport Beach Newport Beach California
United States Cancer Center of Kansas - Newton Newton Kansas
United States Community Cancer Center Foundation Normal Illinois
United States Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut
United States Sutter Cancer Research Consortium Novato California
United States Kaiser Permanente-Oakland Oakland California
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Green Bay Oncology - Oconto Falls Oconto Falls Wisconsin
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Smilow Cancer Hospital-Orange Care Center Orange Connecticut
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Florida Hospital Orlando Orlando Florida
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Radiation Oncology of Northern Illinois Ottawa Illinois
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Kaiser Permanente - Panorama City Panorama City California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Cancer Center Post Falls Idaho
United States Geisinger Medical Oncology-Pottsville Pottsville Pennsylvania
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Rapid City Regional Hospital Rapid City South Dakota
United States Penn State Health Saint Joseph Medical Center Reading Pennsylvania
United States Kaiser Permanente-Redwood City Redwood City California
United States Beebe Health Campus Rehoboth Beach Delaware
United States Annie Penn Memorial Hospital Reidsville North Carolina
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 Kaiser Permanente-Richmond Richmond California
United States Reid Health Richmond Indiana
United States Kaiser Permanente-Riverside Riverside California
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic Rochester Minnesota
United States SwedishAmerican Regional Cancer Center/ACT Rockford Illinois
United States Penobscot Bay Medical Center Rockport Maine
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Saint John's Clinic-Rolla-Cancer and Hematology Rolla Missouri
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 Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States Sutter General Hospital Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Saint Mary's of Michigan Saginaw Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
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 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Cancer Center of Kansas - Salina Salina Kansas
United States Peninsula Regional Medical Center Salisbury Maryland
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 Kootenai Cancer Clinic Sandpoint Idaho
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 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Nanticoke Memorial Hospital Seaford Delaware
United States Pacific Medical Center-First Hill Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States Grand View Hospital Sellersville Pennsylvania
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Welch Cancer Center Sheridan Wyoming
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
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 Kaiser Permanente-South San Francisco South San Francisco California
United States Providence Hospital-Southfield Cancer Center Southfield Michigan
United States Cancer Research for the Ozarks NCORP Springfield Missouri
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Geisinger Medical Group State College Pennsylvania
United States Iredell Memorial Hospital Statesville North Carolina
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 Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente-Stockton Stockton California
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Cancer Care Specialists of Illinois-Swansea Swansea Illinois
United States Flower Hospital Sylvania Ohio
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States The Toledo Hospital/Toledo Children's Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
United States Charlotte Hungerford Hospital Center for Cancer Care Torrington Connecticut
United States Upper Valley Medical Center Troy Ohio
United States Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States The University of Arizona Medical Center-University Campus Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States Inspira Medical Center Vineland Vineland New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States John Muir Medical Center-Walnut Creek Walnut Creek California
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States MedStar Georgetown University Hospital Washington District of Columbia
United States MedStar Washington Hospital Center Washington District of Columbia
United States Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut
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 Fulton County Health Center Wauseon Ohio
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Reading Hospital West Reading Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Saint Clare's Hospital Weston Wisconsin
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Via Christi Regional Medical Center Wichita Kansas
United States Wichita NCI Community Oncology Research Program Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Southeastern Medical Oncology Center-Wilson Wilson North Carolina
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Inspira Medical Center Woodbury Woodbury New Jersey
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Kaiser Permanente Woodland Hills California
United States Wright-Patterson Medical Center Wright-Patterson Air Force Base Ohio
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Main Line Health NCORP Wynnewood Pennsylvania
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Gene Expression Profiles Bone marrow compared to that of an aspirate taken at the site of the EMP. Data will be log-transformed before analysis. Exploratory analyses will examine underlying distributions using boxplots, density plots, scatter plots, etc. For differential expression analysis of the two sample types t-tests will be conducted on genes. False discovery rate will be used to control the average false positive proportions among selected genes. Genes will be ranked by their q-value and pathway analysis conducted upon selected genes to determine biological plausibility and relevance to molecular functionality. Up to 3 years
Other Incidence of CR by PET, Defined as the Disappearance of All Focal Lesions and the Resolution of EMD Univariate and multivariate logistic regression will be used to determine the impact of biochemical CR on CR by PET. In the multivariate analysis adjustment for standard prognostic factors such as age, albumin, beta-2 microglobulin, serum creatinine, c-reactive protein and lactate dehydrogenase will be included. Up to week 45
Primary Progression-free Survival Assessed in each arm using the method of Kaplan Meier and compared between arms using the stratified long-rank test. Progression is defined using the International Uniform Response Criteria for Multiple Myeloma as new or increase in size of existing bone lesions or soft tissue plasmacytomas; or development of hypercalcemia attributable solely to MM; or = 25% increase from baseline or lowest response level of either serum M protein, urine M protein, difference in involved & uninvolved serum free light chain level or bone marrow plasma cell percentage. From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 2 years
Secondary Overall Survival Assessed in each arm using the method of Kaplan Meier and compared between arms using the stratified log-rank test. From date of registration to date of death due to any cause, assessed up to 3 years
Secondary Best Overall Response - Partial Response (PR), Very Good Partial Response (VGPR), Unconfirmed PR (uPR), Stable Disease (SD) Progression (PROG) Per International Uniform Response Criteria for Multiple Myeloma PR- = 50% reduction in size of soft tissue plasmacytomas & plasma cells; = 50% decrease in serum & reduction in urine M protein = 90% or to < 200 mg/24hr or = 50% decrease in difference in uninvolved & involved serum free light chain levels; VGPR- PR + Serum and urine M proteins detectable by immunofixation but not on electrophoresis or = 90% reduction in serum M protein & urine M protein < 100 mg/24 hrs; uPR- 1 objective status of PR, but confirmation studies are not done, or do not meet the requirements necessary to confirm response; SD- does not meet criteria for sCR, CR, VGPR, PR or PROG; PROG- new or increase in size of existing bone lesions or soft tissue plasmacytomas/ development of hypercalcemia attributable solely to MM/ = 25% increase from baseline/ lowest response level of either serum or Urine M protein, difference in involved & uninvolved serum free light chain level or bone marrow plasma cell percentage. From date of registration to date of best response while on study treatment
Secondary Progression-free Survival of Crossover Group Assessed in the crossover arm using the method of Kaplan Meier. Progression is defined using the International Uniform Response Criteria for Multiple Myeloma as new or increase in size of existing bone lesions or soft tissue plasmacytomas; or development of hypercalcemia attributable solely to MM; or = 25% increase from baseline or lowest response level of either serum M protein, urine M protein, difference in involved & uninvolved serum free light chain level or bone marrow plasma cell percentage. From date of crossover to date of subsequent documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years from randomization
Secondary Overall Survival Crossover Group Assessed in the crossover arm using the method of Kaplan Meier. From date of crossover to date of death due to any cause, assessed up to 3 years from randomization
See also
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