A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma



Status:Active, not recruiting
Conditions:Hematology, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2013

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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.


Key Inclusion Criteria:

- 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.

Key Exclusion Criteria:

- 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.
We found this trial at
22
sites
3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Charlotte, North Carolina 28211
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Dallas, TX
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Detroit, Michigan 48201
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Hattiesburg, Mississippi 39401
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Hot Springs, Arkansas 71913
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Hot Springs, AR
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Marrero, Louisiana 70072
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8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
(414) 805-6840
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
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Morgantown, West Virginia 26506
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New York, New York 10065
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Omaha, Nebraska 68114
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Santa Rosa, California 95403
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Watertown, South Dakota
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