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Trial record 41 of 184 for:    carfilzomib OR pr-171

Carfilzomib Multiple Myeloma Expanded Access Protocol for Patients With Relapsed and Refractory Disease

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ClinicalTrials.gov Identifier: NCT01410500
Expanded Access Status : Approved for marketing
First Posted : August 5, 2011
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Multiple Myeloma Research Foundation
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date August 2, 2011
First Posted Date August 5, 2011
Last Update Posted Date May 2, 2017
 
Descriptive Information
Brief Title Carfilzomib Multiple Myeloma Expanded Access Protocol for Patients With Relapsed and Refractory Disease
Brief Summary The purpose of this study is to expand upon the safety data for carfilzomib by providing expanded access to patients with relapsed and refractory multiple myeloma who are unable to enroll in any other ongoing carfilzomib trial.
Detailed Description This is a multi-center, expanded access, open label study of carfilzomib for patients with relapsed and refractory multiple myeloma. The study is designed to provide access to patients with relapsed and refractory disease that have received at least 4 prior regimens and are not eligible for any other enrolling carfilzomib Onyx-sponsored studies enrolling patients in the United States.
Study Type Expanded Access
Intervention Drug: Carfilzomib
Carfilzomib was administered as an intravenous (IV) infusion over approximately 10 minutes on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles at a dose of 20 mg/m² on Days 1 and 2 of Cycle 1 and 27 mg/m² for all infusions thereafter until Cycle 12. For Cycle 13 and higher for those still receiving carfilzomib, the carfilzomib infusion schedule was abridged to Days 1, 2, 15, and 16 of each subsequent 28-day cycle. Carfilzomib treatment was continued until disease progression, diagnosis of a new malignancy, unacceptable toxicity, withdrawal of consent, or the study was terminated
Other Name: Kyprolis®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01410500
Responsible Party Amgen
Study Sponsor Amgen
Collaborators Multiple Myeloma Research Foundation
Investigators
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2017