Status:
COMPLETED
A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
Lead Sponsor:
Amgen
Conditions:
Multiple Myeloma
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 carfi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 9 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2017
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00884312
Start Date
April 9 2009
End Date
May 17 2017
Last Update
May 14 2018
Active Locations (23)
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1
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
2
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
3
City of Hope National Medial Center
Duarte, California, United States, 91010
4
University of California Medical Center
San Francisco, California, United States, 94143