An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
The goal of this clinical research study is to learn if Kyprolis® (carfilzomib) continues to be safe and effective when given long-term (beyond your previous carfilzomib treatment) to treat myeloma.
Disease Group: Myeloma
Treatment Agent: Carfilzomib
Treatment Location: Both at MD Anderson & Other Sites
Sponsor: Onyx Therapeutics, Inc.
To evaluate the safety and efficacy of long-term or continuing carfilzomib treatment in subjects who have completed a previous carfilzomib treatment study. For our purpose at MD Anderson we will be enrolling patients with Multiple Myeloma only.
IRB Review and Approval Date: 10/19/2010
Recruitment Status: Closed
Projected Accrual: 100
1) Previous completion of a carfilzomib study within 90 days prior to
first dose of extension study drug.
2) Disease Assessments performed within 30 days prior to first dose of maintenance study drug.
3) Written informed consent in accordance with federal, local, and institutional guidelines
4) 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.
5) 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.
1) Administration of an intervening chemotherapy between the time of
previous carfilzomib study termination and first dose of maintenance
2) Pregnant or lactating females
3) Diagnosis of a new malignancy of a different tumor type.