A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
Conditions
Advanced Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Filanesib, KSP (Eg5) inhibitor; intravenous Type: Drug
Name: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Key Inclusion Criteria:

- Patients with confirmed multiple myeloma whose treatment history must include all of the following:

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.

Key Exclusion Criteria:

- 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.
Locations
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Status: Recruiting
Contact: Liz Busby - 205-934-0337 - lizbusby@uab.edu
City of Hope
Duarte, California, United States
Status: Recruiting
Contact: Nitya Nathwani, MD - 626-256-4673 - nnathwani@coh.org
University of California, San Francisco Medical Center
San Francisco, California, United States
Status: Recruiting
Contact: Gerry Pelle-Day - 415-476-4765 - gpelle-day@cc.ucsf.edu
University of Colorado
Aurora, Colorado, United States
Status: Recruiting
Contact: Derek Schatz - 720-848-0628 - derek.schatz@ucdenver.edu
Colorado Blood Cancer Institute
Denver, Colorado, United States
Status: Recruiting
Contact: Juli Murphy - 720-754-4890 - juli.murphy@healthonecares.com
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Status: Recruiting
Contact: Stephanie D. Sellers - 203-737-8358 - stephanie.sellers@yale.edu
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States
Status: Recruiting
Contact: Kenisha Barron - kbarron@emory.edu
Northwestern University
Chicago, Illinois, United States
Status: Recruiting
Contact: Stephanie Barath - 312-695-1316 - stephanie.barath@northwestern.edu
Rush University Medical Center
Chicago, Illinois, United States
Status: Recruiting
Contact: Agne Paner, MD - 312-942-5157 - agne_paner@rush.edu
Decatur Memorial Hospital
Decatur, Illinois, United States
Status: Recruiting
Contact: Karen Cheek - 217-876-4740 - kcheek@dmhhs.org
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States
Status: Recruiting
Contact: Kelly Daniels - 913-945-6591 - kdaniels2@kumc.edu
University of Kentucky
Lexington, Kentucky, United States
Status: Recruiting
Contact: Gregory Monohan, MD - 859-257-3379
Norton Cancer Institute
Louisville, Kentucky, United States
Status: Recruiting
Contact: Heather Woolridge - 502-899-6147 - heather.woolridge@nortonhealthcare.org
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Status: Recruiting
Contact: Natalie Bongiorno, RN, MSHS - 301-571-2016 - nbongiorno@ccbdmd.com
Tufts Medical Center
Boston, Massachusetts, United States
Status: Recruiting
Contact: Jodi Jensen - 617-636-5558 - jjensen@tuftsmedicalcenter.org
Karmanos Cancer Institute
Detroit, Michigan, United States
Status: Recruiting
Contact: Silva Pregja - 313-576-8673 - pregjas@karmanos.org
Washington University in St. Louis
St. Louis, Missouri, United States
Status: Recruiting
Contact: Brett Ramsey - 314-747-2844 - baramsey@dom.wustl.edu
Nebraska Hematology Oncology, P.C.
Lincoln, Nebraska, United States
Status: Recruiting
Contact: Kent Disney, RN, BSN, CCRP - 402-484-4911 - kdisney@yourcancercare.com
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Status: Recruiting
Contact: - 702-952-3350
Mount Sinai Medical Center
New York, New York, United States
Status: Recruiting
Contact: Lisa La - 212-241-8615 - lisa.la@mssm.edu
NY Presbyterian - Weill Cornell Medical Center
New York, New York, United States
Status: Recruiting
Contact: Kathleen Pogonowski, RN - 212-746-6738 - Kap9111@med.cornell.edu
Levine Cancer Institute
Charlotte, North Carolina, United States
Status: Recruiting
Contact: Mary Tipton, RN, BSN, MHEd, CCRP - 704-355-6079
Duke Cancer Center
Durham, North Carolina, United States
Status: Recruiting
Contact: Kimberly Oates - 919-668-6524 - kimberly.bartlett@duke.edu
Cleveland Clinic
Cleveland, Ohio, United States
Status: Recruiting
Contact: Jason Valent, MD - 216-445-6831 - Valentj3@ccf.org
Medical University of South Carolina
Charleston, South Carolina, United States
Status: Recruiting
Contact: Shanta Salzer - 843-792-1463 - salzers@musc.edu
UT Southwestern Medical Center
Dallas, Texas, United States
Status: Recruiting
Contact: Blake Pond - 214-648-7030 - blake.pond@utsouthwestern.edu
MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Kim Rankin - 713-794-1882 - karankin@mdanderson.org
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Status: Recruiting
Contact: Aaron Ernst - 801-587-4487 - aaron.ernst@hci.utah.edu
Cancer Care Northwest
Spokane Valley, Washington, United States
Status: Recruiting
Contact: Rose Miller - 509-228-1680 - research@ccnw.net
Institut Jules Bordet
Bruxelles, Belgium
Status: Recruiting
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Status: Recruiting
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Status: Recruiting
Contact: Nizar Bahlis, MD - 403-994-1880 - nbahlis@ucalgary.ca
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
Status: Recruiting
Contact: Darrell White, MD - 902-473-4642
Jewish General Hospital
Montreal, Quebec, Canada
Status: Recruiting
Contact: Dennis Baltzis, PhD - 514-340-8222 - dbaltzis@jgh.mcgill.ca
Centre Hospitalier Lyon-Sud
Bierre-Benite Cedex, France
Status: Recruiting
Hopital Claude Huriez
Lille Cedex, France
Status: Recruiting
Institut Paoli Calmettes
Marseille Cedex 9, France
Status: Recruiting
CHU Hotel Dieu
Nantes Cedex, France
Status: Recruiting
G.H.U Caremeau
Nimes Cedex 9, France
Status: Recruiting
Institut Universitaire de Cancer
Toulouse, France
Status: Recruiting
CHU tours-Hopital Bretonneau
Tours Cedex, France
Status: Recruiting
CHU de Nancy - Hopital de Brabois
Vandoeuvre les Nancy, France
Status: Recruiting
TU Dresden Medizinische Fakultat, Medizinische Klinik und Poliklinik I
Dresden, Germany
Status: Recruiting
Asklepios Kliniken Hamburg GmbH
Hamburg, Germany
Status: Recruiting
University Hospital Heidelberg
Heidelberg, Germany
Status: Recruiting
University Hospital Leipzig
Leipzig, Germany
Status: Recruiting
University of Tubingen
Tubingen, Germany
Status: Recruiting
Julius Maximilians Universitat Wurzburg
Wurzburg, Germany
Status: Recruiting
General Hospital of Athens "Evangelismos"
Athens, Greece
Status: Recruiting
University of Athens School of Medicine
Athens, Greece
Status: Recruiting
Hospital Germans Trias i Pujol
Badalona, Spain
Status: Recruiting
Hospital Clinic de Barcelona
Barcelona, Spain
Status: Recruiting
Hospital Clinico Universitario de Valencia
Valencia, Spain
Status: Recruiting
Hospital Universitario La Fe
Valencia, Spain
Status: Recruiting
Hospital Quiron de Zaragoza
Zaragoza, Spain
Status: Recruiting
Barts Health NHS Trust
London, United Kingdom
Status: Recruiting
Kings College Hospital NHS Foundation Trust
London, United Kingdom
Status: Recruiting
Southhampton General Hospital
Southhampton, United Kingdom
Status: Recruiting
The Royal Marsden NHS Foundation Trust
Surrey, United Kingdom
Status: Recruiting
New Cross Hospital
Wolverhampton, United Kingdom
Status: Recruiting
Start Date
May 2014
Sponsors
Array BioPharma
Source
Array BioPharma
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page