A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
3 other identifiers
interventional
154
8 countries
60
Brief Summary
The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160 patients from North America and Europe will be enrolled in this study. Eligible patients will have received at least two prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2014
Typical duration for phase_2
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
March 20, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2017
CompletedOctober 19, 2020
October 1, 2020
2.2 years
March 19, 2014
October 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
In patients with low Baseline alpha 1-acid glycoprotein (AAG), assess the efficacy of the study drug in terms of objective response rate.
up to 2 years
Secondary Outcomes (7)
In patients with high Baseline AAG, assess the efficacy of the study drug in terms of objective response rate.
up to 2 years
In all patients, assess the efficacy of the study drug in terms of duration of response.
up to 2 years
In all patients, assess the efficacy of the study drug in terms of progression-free survival.
up to 2 years
In all patients, assess the efficacy of study drug in terms of overall survival.
up to 2 years
In all patients, assess the safety of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
up to 2 years
- +2 more secondary outcomes
Study Arms (1)
Filanesib
EXPERIMENTALInterventions
standard of care
Eligibility Criteria
You may qualify if:
- Patients with confirmed multiple myeloma whose treatment history must include all of the following:
- Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy).
- Received at least 2 cycles of a bortezomib-containing regimen and 2 cycles of a lenalidomide-containing regimen, unless intolerant to these agents (defined as requiring discontinuation due to toxicity).
- Disease refractory to a carfilzomib-containing regimen and/or a pomalidomide containing regimen. Refractory is defined as either failure to achieve a minimal response (MR) or better while on therapy, or development of progressive disease (PD) while on therapy or within 60 days from last dose of therapy.
- Measurable multiple myeloma disease, defined as meeting at least one of the following criteria within 14 days prior to first dose of study drug:
- A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 1.0 g/dL.
- Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
- Involved serum free light chain (FLC) level ≥ 10 mg/dL, provided the serum FLC ratio is abnormal.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study drug.
- Adequate hematology, hepatic and renal function laboratory values within 14 days prior to first dose of study drug.
- Additional criteria exist.
You may not qualify if:
- Prior treatment with filanesib (ARRY-520) 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).
- Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study drug.
- 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 drug. 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.
- Use of an investigational agent that is not expected to be cleared by the time of first dose of study drug or that has been demonstrated to have prolonged side effects. Patients must have recovered from all side effects to a Grade 0 or 1 (except alopecia and neuropathy).
- Any severe concurrent disease or condition (including severe graft-versus-host disease, requirement for dialysis, symptomatic congestive heart failure \[New York Heart Association Class III or IV\], unstable angina pectoris, cardiac arrhythmia) which, 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 (60)
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35249, United States
City of Hope
Duarte, California, 91010, United States
University of California, San Francisco Medical Center
San Francisco, California, 94143, United States
University of Colorado
Aurora, Colorado, 80045, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06510, United States
Emory University, Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, 66205, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Washington University in St. Louis
St Louis, Missouri, 63130, United States
Nebraska Hematology Oncology, P.C.
Lincoln, Nebraska, 68506, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
NY Presbyterian - Weill Cornell Medical Center
New York, New York, 10065, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Cancer Care Northwest
Spokane Valley, Washington, 99216, United States
Institut Jules Bordet
Brussels, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, Canada
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre Hospitalier Lyon-Sud
Bierre-Benite Cedex, France
Hopital Claude Huriez
Lille, France
Institut Paoli Calmettes
Marseille, France
CHU Hotel Dieu
Nantes, France
G.H.U Caremeau
Nîmes, France
Institut Universitaire de Cancer
Toulouse, France
CHU tours-Hopital Bretonneau
Tours, France
CHU de Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, France
TU Dresden Medizinische Fakultat, Medizinische Klinik und Poliklinik I
Dresden, Germany
Asklepios Kliniken Hamburg GmbH
Hamburg, Germany
University Hospital Heidelberg
Heidelberg, Germany
University Hospital Leipzig
Leipzig, Germany
University of Tubingen
Tübingen, Germany
Julius Maximilians Universitat Wurzburg
Würzburg, Germany
General Hospital of Athens "Evangelismos"
Athens, Greece
University of Athens School of Medicine
Athens, Greece
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital Universitario La Fe
Valencia, Spain
Hospital Quiron de Zaragoza
Zaragoza, Spain
Barts Health NHS Trust
London, United Kingdom
Kings College Hospital NHS Foundation Trust
London, United Kingdom
Southhampton General Hospital
Southhampton, United Kingdom
The Royal Marsden NHS Foundation Trust
Surrey, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
March 19, 2014
First Posted
March 20, 2014
Study Start
May 1, 2014
Primary Completion
July 1, 2016
Study Completion
September 5, 2017
Last Updated
October 19, 2020
Record last verified: 2020-10
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.