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