Trial record 1 of 19 for:    s1304
Previous Study | Return to List | Next Study

S1304, Testing Two Doses of Carfilzomib With Dexamethasone for Relapsed or Refractory Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Southwest Oncology Group
Sponsor:
Collaborators:
Onyx Pharmaceuticals
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01903811
First received: July 16, 2013
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

This randomized phase II trial studies how well two doses of carfilzomib work with dexamethasone in treating patients with relapsed or refractory multiple myeloma. 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 or by stopping them from dividing. Giving carfilzomib together with dexamethasone may kill more cancer cells. This study is looking to see if giving a higher or lower dose of carfilzomib with dexamethasone is more beneficial than the other.


Condition Intervention Phase
Relapsed or Refractory Multiple Myeloma
Drug: dexamethasone
Drug: carfilzomib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: S1304, A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) With Dexamethasone for Multiple Myeloma Patients With Relapsed or Refractory Disease

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Assessed in each arm using the method of Kaplan Meier and compared between arms using the stratified long-rank test.


Secondary Outcome Measures:
  • Response rate (stringent complete response [sCR], complete response [CR], very good partial response [VGPR], partial response [PR]) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Assessed in each arm and compared between arms using Fisher's exact test.

  • Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Assessed in each arm using the method of Kaplan Meier and compared between arms using the stratified log-rank test.


Estimated Enrollment: 140
Study Start Date: September 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 cycle 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.
Drug: dexamethasone
given IV
Other Name: decadron
Drug: carfilzomib
given IV
Other Names:
  • kyprolis
  • PR-171
Experimental: 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 cycle 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.
Drug: dexamethasone
given IV
Other Name: decadron
Drug: carfilzomib
given IV
Other Names:
  • kyprolis
  • PR-171

Detailed 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 for 3 years from initial registration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • REGISTRATION STEP 1: INITIAL RANDOMIZATION
  • Patients must have a confirmed diagnosis of symptomatic multiple myeloma and must be 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 28 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 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 must be off myelosuppressive chemotherapy and non-myelosuppressive chemotherapy and external beam radiation therapy (XRT) for >= 28 days (>= 6 weeks for nitrosoureas) and must have recovered to =< grade 1 from all treatment associated toxicities prior to registration; patients are allowed to have treatment for up to 7 days with pulse steroids for a myeloma-related complication prior to registration, as considered necessary by the treating physician
  • 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) 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 been able to complete their last treatment cycle prior to progression at the full assigned dose (i.e. no dose reduction for toxicity)
  • 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 coordinator for determination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903811

Contacts
Contact: Sandi J Fredette 210/614-8808 sfredette@swog.org
Contact: Dana B Sparks, MAT 210/614-8808 dsparks@swog.org

  Hide Study Locations
Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Sikander Ailawadhi    323-865-0451      
Principal Investigator: Sikander Ailawadhi         
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Joseph M. Tuscano    916-734-3089      
Principal Investigator: Joseph M. Tuscano         
United States, Connecticut
Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
United States, Georgia
Saint Joseph's-Candler Health System Recruiting
Savannah, Georgia, United States, 31405
Contact: Ovidiu G. Negrea    912-350-8568      
Principal Investigator: Ovidiu G. Negrea         
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Kootenai Medical Center Recruiting
Coeur D'Alene, Idaho, United States, 83814
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Kootenai Cancer Center Recruiting
Post Falls, Idaho, United States, 83854
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, Illinois
Saint Joseph Medical Center Recruiting
Bloomington, Illinois, United States, 61701
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Bloomington Recruiting
Bloomington, Illinois, United States, 61701
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Galesburg Cottage Plaza Office Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Hinsdale Hematology Oncology Associates Incorporated Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Elyse Schneiderman    630-654-1790    info@hhoaltd.com   
Principal Investigator: Elyse Schneiderman         
Illinois CancerCare-Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Tulio E. Rodriguez    708-226-4357      
Principal Investigator: Tulio E. Rodriguez         
Illinois CancerCare-Monmouth Recruiting
Monmouth, Illinois, United States, 61462
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Community Cancer Center Foundation Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Pekin Recruiting
Pekin, Illinois, United States, 61603
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Pekin Cancer Treatment Center Recruiting
Pekin, Illinois, United States, 61554
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61603
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
Mercy Medical Center-Sioux City Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
Saint Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
Siouxland Hematology Oncology Associates Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
United States, Kansas
Cancer Center of Kansas - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Manhattan Recruiting
Manhattan, Kansas, United States, 66502
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - McPherson Recruiting
McPherson, Kansas, United States, 67460
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Associates In Womens Health Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Main Office Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Wichita Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Wichita CCOP Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
United States, Louisiana
Hematology/Oncology Clinic LLP Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Hana F. Safah    504-988-6121      
Principal Investigator: Hana F. Safah         
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Hana F. Safah    504-988-6121      
Principal Investigator: Hana F. Safah         
United States, Maine
Harold Alfond Center for Cancer Care Recruiting
Augusta, Maine, United States, 04330
Contact: Thomas H. Openshaw    207-973-4274      
Principal Investigator: Thomas H. Openshaw         
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Thomas H. Openshaw    207-973-4274      
Principal Investigator: Thomas H. Openshaw         
Penobscot Bay Medical Center Recruiting
Rockport, Maine, United States, 04856
Contact: Thomas H. Openshaw    207-973-4274      
Principal Investigator: Thomas H. Openshaw         
United States, Massachusetts
Beverly Hospital Recruiting
Beverly, Massachusetts, United States, 01915
Contact: Angus P. McIntyre    978-283-4000      
Principal Investigator: Angus P. McIntyre         
Addison Gilbert Hospital Recruiting
Gloucester, Massachusetts, United States, 01930
Contact: Angus P. McIntyre    978-283-4000      
Principal Investigator: Angus P. McIntyre         
United States, Michigan
Bixby Medical Center Recruiting
Adrian, Michigan, United States, 49221
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Hickman Cancer Center Recruiting
Adrian, Michigan, United States, 49221
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Michigan Cancer Research Consortium Community Clinical Oncology Program Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Oakwood Hospital Recruiting
Dearborn, Michigan, United States, 48124
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Green Bay Oncology - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: Matthew L. Ryan    800-432-6049      
Principal Investigator: Matthew L. Ryan         
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48502
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Green Bay Oncology - Iron Mountain Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: Matthew L. Ryan    800-432-6049      
Principal Investigator: Matthew L. Ryan         
Allegiance Health Recruiting
Jackson, Michigan, United States, 49201
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Mercy Memorial Hospital Recruiting
Monroe, Michigan, United States, 48162
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Community Cancer Center of Monroe Recruiting
Monroe, Michigan, United States, 48162
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Saint Joseph Mercy Port Huron Recruiting
Port Huron, Michigan, United States, 48060
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Saint John Macomb-Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
United States, Missouri
CoxHealth Cancer Center Recruiting
Branson, Missouri, United States, 65616
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Alan P. Lyss    800-392-0936      
Principal Investigator: Alan P. Lyss         
Saint Luke's Hospital Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Donald F. Busiek    314-205-6936      
Principal Investigator: Donald F. Busiek         
Capital Region Medical Center-Goldschmidt Cancer Center Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Alan P. Lyss    800-392-0936      
Principal Investigator: Alan P. Lyss         
Freeman Health System Recruiting
Joplin, Missouri, United States, 64804
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Phelps County Regional Medical Center Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Saint John's Clinic-Rolla-Cancer and Hematology Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan P. Lyss    800-392-0936      
Principal Investigator: Alan P. Lyss         
Saint John's Mercy Medical Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Saint Louis Cancer and Breast Institute-South City Recruiting
Saint Louis, Missouri, United States, 63109
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Recruiting
Springfield, Missouri, United States, 65802
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
United States, Montana
Saint Vincent Healthcare Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Billings Clinic Recruiting
Billings, Montana, United States, 59107-7000
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Montana Cancer Consortium CCOP Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint James Community Hospital and Cancer Treatment Center Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Benefis Healthcare- Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint Peter's Community Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint Patrick Hospital - Community Hospital Recruiting
Missoula, Montana, United States, 59802
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, Nevada
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
United States, North Carolina
Randolph Hospital Recruiting
Asheboro, North Carolina, United States, 27203
Contact: James M. Granfortuna    336-832-0821      
Principal Investigator: James M. Granfortuna         
Wayne Memorial Hospital Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins    919-580-0000      
Principal Investigator: James N. Atkins         
Cone Health Cancer Center Recruiting
Greensboro, North Carolina, United States, 27403
Contact: James M. Granfortuna    336-832-0821      
Principal Investigator: James M. Granfortuna         
Margaret R Pardee Memorial Hospital Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: James E. Radford    828-696-4716      
Principal Investigator: James E. Radford         
Kinston Medical Specialists PA Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson    252-559-2200      
Principal Investigator: Peter R. Watson         
Annie Penn Memorial Hospital Recruiting
Reidsville, North Carolina, United States, 27320
Contact: James M. Granfortuna    336-832-0821      
Principal Investigator: James M. Granfortuna         
Iredell Memorial Hospital Recruiting
Statesville, North Carolina, United States, 28677
Contact: Ruby A. Grimm    704-873-5661      
Principal Investigator: Ruby A. Grimm         
United States, Ohio
Strecker Cancer Center-Belpre Recruiting
Belpre, Ohio, United States, 45714
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Toledo Clinic Cancer Centers-Bowling Green Recruiting
Bowling Green, Ohio, United States, 43402
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Doctors Hospital Recruiting
Columbus, Ohio, United States, 43228
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Columbus Oncology and Hematology Associates Inc Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Columbus CCOP Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
The Mark H Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Mount Carmel Health Center West Recruiting
Columbus, Ohio, United States, 43222
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Delaware Health Center-Grady Cancer Center Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Lima Memorial Hospital Recruiting
Lima, Ohio, United States, 45804
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Recruiting
Maumee, Ohio, United States, 43537
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Toledo Clinic Cancer Centers-Maumee Recruiting
Maumee, Ohio, United States, 43537
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Knox Community Hospital Recruiting
Mount Vernon, Ohio, United States, 43050
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Toledo Clinic Cancer Centers-Oregon Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Saint Charles Hospital Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Springfield Regional Medical Center Recruiting
Springfield, Ohio, United States, 45505
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Flower Hospital Recruiting
Sylvania, Ohio, United States, 43560
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Mercy Hospital of Tiffin Recruiting
Tiffin, Ohio, United States, 44883
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Saint Vincent Mercy Medical Center Recruiting
Toledo, Ohio, United States, 43608
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
The Toledo Hospital/Toledo Children's Hospital Terminated
Toledo, Ohio, United States, 43606
Mercy Saint Anne Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
University of Toledo Recruiting
Toledo, Ohio, United States, 43614
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Toledo Clinic Cancer Centers-Toledo Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Toledo Community Hospital Oncology Program CCOP Recruiting
Toledo, Ohio, United States, 43617
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Fulton County Health Center Recruiting
Wauseon, Ohio, United States, 43567
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Saint Ann's Hospital Recruiting
Westerville, Ohio, United States, 43081
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Genesis HealthCare System Recruiting
Zanesville, Ohio, United States, 43701
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: George B. Selby    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: George B. Selby         
Natalie Warren Bryant Cancer Center at Saint Francis Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Joseph P. Lynch    918-494-2200      
Principal Investigator: Joseph P. Lynch         
Surgical Associates Inc Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Joseph P. Lynch    918-494-2200      
Principal Investigator: Joseph P. Lynch         
Oklahoma Oncology Inc Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Joseph P. Lynch    918-494-2200      
Principal Investigator: Joseph P. Lynch         
Warren Cancer Research Foundation Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Joseph P. Lynch    918-494-2200      
Principal Investigator: Joseph P. Lynch         
United States, Pennsylvania
Saint Joseph Medical Center Recruiting
Reading, Pennsylvania, United States, 19605
Contact: Marc A. Rovito    610-378-2336    danielward2@catholichealth.net   
Principal Investigator: Marc A. Rovito         
Grand View Hospital Recruiting
Sellersville, Pennsylvania, United States, 18960
Contact: Anthony J. Magdalinski    215-453-4162    PParsons@gvh.org   
Principal Investigator: Anthony J. Magdalinski         
United States, South Carolina
McLeod Regional Medical Center Recruiting
Florence, South Carolina, United States, 29506
Contact: Rajesh Bajaj    843-679-7256      
Principal Investigator: Rajesh Bajaj         
United States, Texas
Southwest Oncology Group Recruiting
San Antonio, Texas, United States, 78245
Contact: Sikander Ailawadhi    323-865-3913    ailawadh@usc.edu   
Principal Investigator: Sikander Ailawadhi         
United States, Virginia
Fredericksburg Oncology Inc Recruiting
Fredericksburg, Virginia, United States, 22401
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
United States, Wisconsin
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Matthew L. Ryan    800-432-6049      
Principal Investigator: Matthew L. Ryan         
Green Bay Oncology Limited at Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Matthew L. Ryan    800-432-6049      
Principal Investigator: Matthew L. Ryan         
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Matthew L. Ryan    800-432-6049      
Principal Investigator: Matthew L. Ryan         
Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Matthew L. Ryan    800-432-6049      
Principal Investigator: Matthew L. Ryan         
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: Matthew L. Ryan    800-432-6049      
Principal Investigator: Matthew L. Ryan         
Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Matthew L. Ryan    800-432-6049      
Principal Investigator: Matthew L. Ryan         
D N Greenwald Center Recruiting
Mukwonago, Wisconsin, United States, 53149
Contact: Timothy R. Wassenaar    262-928-7878      
Principal Investigator: Timothy R. Wassenaar         
Oconomowoc Memorial Hospital-ProHealth Care Inc Recruiting
Oconomowoc, Wisconsin, United States, 53066-3896
Contact: Timothy R. Wassenaar    262-928-7878      
Principal Investigator: Timothy R. Wassenaar         
Green Bay Oncology - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Matthew L. Ryan    800-432-6049      
Principal Investigator: Matthew L. Ryan         
Saint Nicholas Hospital Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Matthew L. Ryan    800-432-6049      
Principal Investigator: Matthew L. Ryan         
Green Bay Oncology - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Matthew L. Ryan    800-432-6049      
Principal Investigator: Matthew L. Ryan         
Waukesha Memorial Hospital - ProHealth Care Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Timothy R. Wassenaar    262-928-7878      
Principal Investigator: Timothy R. Wassenaar         
United States, Wyoming
Rocky Mountain Oncology Recruiting
Casper, Wyoming, United States, 82609
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Welch Cancer Center Recruiting
Sheridan, Wyoming, United States, 82801
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Sponsors and Collaborators
Southwest Oncology Group
Onyx Pharmaceuticals
Investigators
Study Chair: Sikander Ailawadhi, MD Southwest Oncology Group
Study Chair: Muneer Abidi, MD` Southwest Oncology Group
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01903811     History of Changes
Other Study ID Numbers: S1304, U10CA032102, NCI-2013-00796, S1304
Study First Received: July 16, 2013
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
carfilzomib
relapsed, refractory, multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 22, 2014