A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

Completed · Phase 1

Conditions studied: Multiple Myeloma, Plasma Cell Leukemia

In brief

This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support. This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting). In the second part of this study, patients will receive the best dose(s) and schedule(s) of study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Active, not recruiting).

Key facts

Study ID

NCT01248923

Run by

Array Biopharma, now a wholly owned subsidiary of Pfizer

People needed

55

Starts

2010-12-01

Last updated by the study team

2020-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Clearview Cancer Institute — Huntsville, Alabama, United States
• Arizona Clinical Research Center, Inc. — Tucson, Arizona, United States
• City of Hope — Duarte, California, United States
• Emory University, Winship Cancer Institute — Atlanta, Georgia, United States
• Associates in Oncology/Hematology — Rockville, Maryland, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• NYU Cancer Center — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Charleston Hematology Oncology Associates — Charleston, South Carolina, United States
• The Jones Clinic — Germantown, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Baylor Charles A. Sammons Cancer Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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