A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
NCT ID: NCT02092922
Last Updated: 2020-10-19
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2014-05-31
2017-09-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma
NCT00821249
A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
NCT01989325
Filanesib and Carfilzomib in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
NCT01372540
Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma
NCT00530816
Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma
NCT00511238
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Filanesib
Filanesib, KSP (Eg5) inhibitor; intravenous
multiple dose, single schedule
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
standard of care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Filanesib, KSP (Eg5) inhibitor; intravenous
multiple dose, single schedule
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
standard of care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy).
2. 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).
3. 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:
1. A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 1.0 g/dL.
2. Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
3. 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.
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).
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Nebraska Hematology Oncology, P.C.
Lincoln, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Mount Sinai Medical Center
New York, New York, United States
NY Presbyterian - Weill Cornell Medical Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke Cancer Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Cancer Care Northwest
Spokane Valley, Washington, 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-001051-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4371002
Identifier Type: OTHER
Identifier Source: secondary_id
ARRAY-520-215
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.