A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
NCT ID: NCT01989325
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2013-11-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Carfilzomib + Filanesib
Single 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, proteasome inhibitor; intravenous
multiple dose, single schedule
Filanesib, KSP(Eg5) inhibitor; intravenous
multiple dose, single schedule
Dexamethasone, steroid; oral or intravenous
as indicated, per the carfilzomib prescribing information
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
standard of care
Carfilzomib
Single agent arm.
Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
Carfilzomib, proteasome inhibitor; intravenous
multiple dose, single schedule
Dexamethasone, steroid; oral or intravenous
as indicated, per the carfilzomib prescribing information
Interventions
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Carfilzomib, proteasome inhibitor; intravenous
multiple dose, single schedule
Filanesib, KSP(Eg5) inhibitor; intravenous
multiple dose, single schedule
Dexamethasone, steroid; oral or intravenous
as indicated, per the carfilzomib prescribing information
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
standard of care
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Genesis Cancer Center
Hot Springs, Arkansas, United States
UCLA
Los Angeles, California, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Crescent City Research Consortium
Marrero, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Forrest General Cancer Center
Hattiesburg, Mississippi, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Memorial Sloan Kettering
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Oncology Hematology Care - Blue Ash
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Knight Cancer Institute at Oregon Health & Science University
Portland, Oregon, United States
Prairie Lakes Health Care System
Watertown, South Dakota, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Simmons Cancer Center - UT Southwestern Medical Center
Dallas, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
WVU - Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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ARRAY-520-216
Identifier Type: -
Identifier Source: org_study_id
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