NCT01248923

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Multiple Myeloma, Plasma Cell Leukemia

Interventions

Type	Name	Description
DRUG	ARRY-520, KSP(Eg5) inhibitor; intravenous	Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
DRUG	Bortezomib, proteasome inhibitor; intravenous or subcutaneous	Part 1: standard of care; Part 2: standard of care determined in Part 1.
DRUG	Dexamethasone, steroid; oral	Part 1: standard of care; Part 2: standard of care determined in Part 1.
DRUG	Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous	Part 1: standard of care; Part 2: standard of care.
DRUG	ARRY-520, KSP(Eg5) inhibitor; intravenous	Part 1: multiple dose, escalating
DRUG	Bortezomib, proteasome inhibitor; intravenous or subcutaneous	Part 1: standard of care
DRUG	Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous	Part 1: standard of care

Timeline

• Start date: 2010-12-01
• Primary completion: 2016-03-01
• First posted: 2010-11-25
• Last updated: 2020-09-30

Locations

13 sites across 1 country: United States