Risk Prediction, Prognosis and Management of Cardiac Events among Patients with Multiple Myeloma (20160220)

Study identification

• EU PAS number:
  EUPAS15924
• Study ID:
  17624
• Official title and acronym:
  Risk Prediction, Prognosis and Management of Cardiac Events among Patients with Multiple Myeloma (20160220)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Carfilzomib (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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Optum

Germany

Study timelines

Date when funding contract was signed

Planned: 31/10/2016

Actual: 31/10/2016

Study start date

Planned: 31/10/2016

Actual: 31/10/2016

Data analysis start date

Planned: 31/05/2017

Date of final study report

Planned: 31/05/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)