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

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01410500
First Posted: August 5, 2011
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Multiple Myeloma Research Foundation
Information provided by (Responsible Party):
Amgen
August 2, 2011
August 5, 2011
May 2, 2017
 
Carfilzomib Multiple Myeloma Expanded Access Protocol for Patients With Relapsed and Refractory Disease
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.
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.
Expanded Access
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®
Not Provided
 
Approved for marketing
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01410500
Amgen
Amgen
Multiple Myeloma Research Foundation
Study Director: MD Amgen
Amgen
April 2017