A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols

Completed · Phase 2

Conditions studied: Multiple Myeloma, Solid Tumors

In brief

This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and efficacy of long-term or continuing carfilzomib therapy for patients who previously completed a primary carfilzomib treatment study.

Key facts

Study ID

NCT00884312

Run by

Amgen

People needed

101

Starts

2009-04-09

Expected to finish

2017-05-17

Last updated by the study team

2018-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previous completion of a carfilzomib study within 90 days prior to first dose of maintenance study drug.
• Disease Assessments performed within 30 days prior to first dose of maintenance study drug.
• Written informed consent in accordance with federal, local, and institutional guidelines
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL, within 3 days prior to first dose of maintenance study drug.
• Subjects must agree to adhere to the study visit schedule and other study requirements and receive outpatient treatment and laboratory monitoring at the institution that administers the drug.

You may not qualify if…

• Administration of an intervening chemotherapy between the time of previous carfilzomib study termination and first dose of maintenance study drug.
• Pregnant or lactating females
• Diagnosis of a new malignancy of a different tumor type.

Where it is running

• Pinnacle Oncology Hematology — Scottsdale, Arizona, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States
• City of Hope National Medial Center — Duarte, California, United States
• University of California Medical Center — San Francisco, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Winship Cancer Institute - Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Maryland, Greenebaum Cancer Center — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• John Theurer Cancer Center at Hackensack UMC — Hackensack, New Jersey, United States
• Weill Cornell Medical College — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Texas Oncology Cancer Center — Austin, Texas, United States
• The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• Northwest Cancer Center — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• University of Toronto, Princess Margaret Hospital — Toronto, Ontario, Canada
• Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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