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

Advanced Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989325
• Other study ID #: ARRAY-520-216
• Status: Completed
• Phase: Phase 2
• Start date: November 2013
• Est. completion date: May 2016

Study information

• Verified date: September 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Multiple Myeloma
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Carfilzomib, proteasome inhibitor; intravenous
multiple dose, single schedule
• Filanesib, KSP(Eg5) inhibitor; intravenous
multiple dose, single schedule
• Dexamethasone, steroid; oral or intravenous
as indicated, per the carfilzomib prescribing information
• Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
standard of care

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Robert H. Lurie Comprehensive Cancer Center of Northwestern University	Chicago	Illinois
United States	Oncology Hematology Care - Blue Ash	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Simmons Cancer Center - UT Southwestern Medical Center	Dallas	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Forrest General Cancer Center	Hattiesburg	Mississippi
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	UCLA	Los Angeles	California
United States	Crescent City Research Consortium	Marrero	Louisiana
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	WVU - Mary Babb Randolph Cancer Center	Morgantown	West Virginia
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Memorial Sloan Kettering	New York	New York
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	Knight Cancer Institute at Oregon Health & Science University	Portland	Oregon
United States	St. Joseph Heritage Healthcare	Santa Rosa	California
United States	Prairie Lakes Health Care System	Watertown	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate patient serum levels of alpha 1-acid glycoprotein (AAG) at Baseline and during the treatment period.		18 months
Primary	Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival.		18 months
Secondary	Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of objective response rate.		18 months
Secondary	Assess the safety of both carfilzomib + study drug and single-agent carfilzomib in terms of adverse events, clinical laboratory tests and electrocardiograms.		18 months
Secondary	Characterize the pharmacokinetics (PK) of study drug, carfilzomib and a carfilzomib metabolite in patients treated with carfilzomib + study drug in terms of plasma concentration-time profiles and model-based PK parameters.		6 months
Secondary	Following crossover from single-agent carfilzomib, assess the efficacy of carfilzomib + study drug in terms of objective response rate.		18 months
Secondary	Following crossover from single-agent carfilzomib, assess the safety of carfilzomib + study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.		18 months