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

Amgen

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma; Solid Tumors

Treatments: Drug: Carfilzomib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00884312

20130394 (Other Identifier)

PX-171-010

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Previous completion of a carfilzomib study within 90 days prior to first dose of maintenance 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

Carfilzomib

Experimental group

Description:

Participants received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.

Treatment:

Drug: Carfilzomib