A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
2 other identifiers
interventional
101
2 countries
23
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 carfilzomib treatment study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Apr 2009
Longer than P75 for phase_2 multiple-myeloma
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2009
CompletedFirst Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2017
CompletedResults Posted
Study results publicly available
May 14, 2018
CompletedMay 14, 2018
April 1, 2018
8.1 years
April 16, 2009
April 9, 2018
April 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Peripheral Neuropathy
Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain.
From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Number of Participants With Adverse Events
Adverse events (AEs) were assigned a severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 3.0. Per protocol, adverse events were collected if they led to dose modification or dose discontinuation, were grade ≥ 3 or serious, or were events of peripheral neuropathy (any grade). A serious AE is one that met one or more of the following criteria: * Death * Life threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * A congenital anomaly/birth defect in the offspring of an exposed subject * Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above.
From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Secondary Outcomes (3)
Overall Survival
From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Progression-free Survival
From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Time to Progression
From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Study Arms (1)
Carfilzomib
EXPERIMENTALParticipants 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.
Interventions
Carfilzomib dose levels ranged from 11 to 27 mg/m² for 2- to 10-minute infusions and 36 to 56 mg/m² for 30-minute infusions. Carfilzomib doses were administered on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Dose level reduction to a minimum dose of 11 mg/m² for toxicity was permitted.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (23)
Pinnacle Oncology Hematology
Scottsdale, Arizona, 85258, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
City of Hope National Medial Center
Duarte, California, 91010, United States
University of California Medical Center
San Francisco, California, 94143, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1093, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203-1632, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
Northwest Cancer Center
Houston, Texas, 77090, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
University of Toronto, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Jewish General Hospital
Montreal, Quebec, H3t 1E2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2009
First Posted
April 20, 2009
Study Start
April 9, 2009
Primary Completion
May 17, 2017
Study Completion
May 17, 2017
Last Updated
May 14, 2018
Results First Posted
May 14, 2018
Record last verified: 2018-04