Back to resultsA Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
Primary Purpose
Multiple Myeloma, Solid Tumors
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Carfilzomib
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, proteasome, Hematological, carfilzomib, PR-171
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Pinnacle Oncology Hematology
- Tower Cancer Research Foundation
- City of Hope National Medial Center
- University of California Medical Center
- Colorado Blood Cancer Institute
- H. Lee Moffitt Cancer Center & Research Institute
- Winship Cancer Institute - Emory University
- Northwestern University
- University of Maryland, Greenebaum Cancer Center
- Washington University School of Medicine
- John Theurer Cancer Center at Hackensack UMC
- Weill Cornell Medical College
- Mount Sinai School of Medicine
- Gabrail Cancer Center Research
- The Cleveland Clinic Foundation
- Abramson Cancer Center of the University of Pennsylvania
- Sarah Cannon Research Institute
- Texas Oncology Cancer Center
- The University of Texas, MD Anderson Cancer Center
- Northwest Cancer Center
- Fred Hutchinson Cancer Research Center
- University of Toronto, Princess Margaret Hospital
- Jewish General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Carfilzomib
Arm 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.
Outcomes
Primary Outcome Measures
Number of Participants With Peripheral Neuropathy
Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain.
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.
Secondary Outcome Measures
Overall Survival
Since participants were only followed up to 30 days after administration of last dose of study drug per protocol, Kaplan-Meier estimates of overall survival were not calculated. The number of participants who died within 30 days after administration of last dose of study drug is reported.
Progression-free Survival
Progression-free survival (PFS) was defined as the time between the start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurred first.
Disease progression was determined by the local investigator for regimens with the same baseline using the International Uniform Response Criteria (IMWG-URC) for participants with multiple myeloma and Response Evaluation Criteria in Solid Tumors (RECIST) criteria for solid tumor participants.
PFS was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.
Time to Progression
Time to progression (TTP) was defined as the time between start of treatment to the first documentation of disease progression. TTP was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00884312
Brief Title
A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
Official Title
An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 9, 2009 (Actual)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
May 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Solid Tumors
Keywords
Multiple myeloma, proteasome, Hematological, carfilzomib, PR-171
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carfilzomib
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Other Intervention Name(s)
PR-171, PR171, Kyprolis®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Peripheral Neuropathy
Description
Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain.
Time Frame
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.
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Overall Survival
Description
Since participants were only followed up to 30 days after administration of last dose of study drug per protocol, Kaplan-Meier estimates of overall survival were not calculated. The number of participants who died within 30 days after administration of last dose of study drug is reported.
Time Frame
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.
Title
Progression-free Survival
Description
Progression-free survival (PFS) was defined as the time between the start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurred first.
Disease progression was determined by the local investigator for regimens with the same baseline using the International Uniform Response Criteria (IMWG-URC) for participants with multiple myeloma and Response Evaluation Criteria in Solid Tumors (RECIST) criteria for solid tumor participants.
PFS was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.
Time Frame
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.
Title
Time to Progression
Description
Time to progression (TTP) was defined as the time between start of treatment to the first documentation of disease progression. TTP was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Oncology Hematology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
City of Hope National Medial Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute - Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Maryland, Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack UMC
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
Texas Oncology Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
The University of Texas, MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northwest Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Toronto, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3t 1E2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
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