A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
1 other identifier
interventional
77
1 country
22
Brief Summary
This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease progression occurs. Approximately 75 patients from the US will be enrolled in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2013
22 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
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 5, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedSeptember 16, 2020
September 1, 2020
2.3 years
November 5, 2013
September 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival.
18 months
Secondary Outcomes (5)
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of objective response rate.
18 months
Assess the safety of both carfilzomib + study drug and single-agent carfilzomib in terms of adverse events, clinical laboratory tests and electrocardiograms.
18 months
Characterize the pharmacokinetics (PK) of study drug, carfilzomib and a carfilzomib metabolite in patients treated with carfilzomib + study drug in terms of plasma concentration-time profiles and model-based PK parameters.
6 months
Following crossover from single-agent carfilzomib, assess the efficacy of carfilzomib + study drug in terms of objective response rate.
18 months
Following crossover from single-agent carfilzomib, assess the safety of carfilzomib + study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
18 months
Other Outcomes (1)
Evaluate patient serum levels of alpha 1-acid glycoprotein (AAG) at Baseline and during the treatment period.
18 months
Study Arms (2)
Carfilzomib + Filanesib
EXPERIMENTALSingle agent + Carfilzomib arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information. Filgrastim to be administered per the approved product prescribing information and institutional guidelines.
Carfilzomib
EXPERIMENTALSingle agent arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
Interventions
multiple dose, single schedule
as indicated, per the carfilzomib prescribing information
standard of care
Eligibility Criteria
You may qualify if:
- Confirmed multiple myeloma with measurable disease.
- Disease refractory to last myeloma regimen.
- Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study treatment.
- Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.
- Additional criteria exist.
You may not qualify if:
- Prior treatment with carfilzomib, filanesib, or any other KSP inhibitor.
- Past or current plasma cell leukemia.
- Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
- Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment.
- Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study treatment.
- Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study treatment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.
- Known pulmonary hypertension of any severity.
- Concurrent cardiac disease that, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C.
- Acute active infection requiring treatment.
- Additional criteria exist.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (22)
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
UCLA
Los Angeles, California, 90095, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611, United States
Crescent City Research Consortium
Marrero, Louisiana, 70072, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Forrest General Cancer Center
Hattiesburg, Mississippi, 39401, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Memorial Sloan Kettering
New York, New York, 10065, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Oncology Hematology Care - Blue Ash
Cincinnati, Ohio, 45242, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Knight Cancer Institute at Oregon Health & Science University
Portland, Oregon, 97239, United States
Prairie Lakes Health Care System
Watertown, South Dakota, 57201, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Simmons Cancer Center - UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
WVU - Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2013
First Posted
November 21, 2013
Study Start
November 1, 2013
Primary Completion
February 1, 2016
Study Completion
May 1, 2016
Last Updated
September 16, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.