NCT00821249

A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-phase study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL), who have already received at least two previous treatments, will receive investigational study drug ARRY-520. The study has 3 parts. In the first part of the study, Phase 1, patients will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Active, not recruiting). In the second part of the study, Phase 2, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in Part 2 (Active, not recruiting). In the third part of the study, Phase 2 with Dexamethasone, patients will receive the best dose of the study drug determined from the first part of the study, in combination with dexamethasone, and will be followed to evaluate what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in Part 3 (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; Part 3: multiple dose, single schedule.
DRUG	Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous	Part 1: standard of care; Part 2: standard of care; Part 3: standard of care.
DRUG	Dexamethasone, steroid; oral	Part 3: standard of care.

Timeline

• Start date: 2009-01-01
• Primary completion: 2016-03-16
• Completion: 2016-03-16
• First posted: 2009-01-13
• Last updated: 2020-10-19

Locations

5 sites across 1 country: United States