Status: Ongoing First registered on: 20/10/2016
Last updated on: 02/02/2017
1. Study identification
EU PAS Register NumberEUPAS15924
Official titleRisk Prediction, Prognosis and Management of Cardiac Events among Patients with Multiple Myeloma (20160220)
Study title acronym
Study typeObservational study
Brief description of the studyCarfilzomib (Kyprolis) is a proteasome inhibitor indicated for the treatment of patients with advanced multiple myeloma (MM). Cardiac events in patients with MM have been associated with several classes of anti-MM treatments, including chemotherapy agents, immunomodulatory drugs, and proteasome inhibitors. While data on cardiovascular (CV) safety related to carfilzomib exists, uncertainties in the real world use of carfilzomib remain. The aim of this protocol is to address gaps in the current understanding of the occurrence of cardiac events among MM patients treated with carfilzomib using a real world data source. Due to the availability of results from a completed observational study and the anticipated results from an ongoing observational study on carfilzomib exposure and cardiac events, this study has been cancelled as of 27 January 2017.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameAmgen Inc.
Centre locationUSA
Details of (Primary) lead investigator
Title Dr
Last name Amgen Inc.
First name Global Development Leader
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?1

Optum
Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/10/201631/10/2016
Start date of data collection31/10/201631/10/2016
Start date of data analysis31/05/2017
Date of interim report, if expected
Date of final study report31/05/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAmgen100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Amgen Inc.
First name Global Development Leader
Address line 1One Amgen Center Drive
Address line 2 
Address line 3 
CityThousand Oaks 
Postcode91320-1799 
CountryUnited States
Phone number (incl. country code)18054473505 
Alternative phone number 
Fax number (incl. country code) 
Email address medinfo@amgen.com
Public Enquiries
Title Dr 
Last name Amgen Inc. 
First name Global Development Leader 
Address line 1One Amgen Center Drive 
Address line 2 
Address line 3 
CityThousand Oaks 
Postcode91320-1799 
CountryUnited States 
Phone number (incl. country code)18054473505 
Alternative phone number 
Fax number (incl. country code) 
Email address medinfo@amgen.com 
Top