NCT01034553

Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase I/II Study of Combination of Aurora Kinase Inhibitor MLN8237 and Bortezomib in Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Aurora A kinase inhibitor MLN8237 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving aurora A kinase inhibitor MLN8237 together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated doses (MTD) with the combination of MLN8237 and bortezomib. (Phase I) II. To describe the toxicities associated with the combination of MLN8237 and bortezomib. (Phase I) III. To evaluate the overall response rate to the combination of MLN8237 and bortezomib in patients with relapsed or refractory multiple myeloma. (Phase II) SECONDARY OBJECTIVE: I. To assess progression-free survival in patients treated with this combination. (Phase II) II. To assess overall survival in patients treated with this combination.(Phase II) OUTLINE: This is a phase I dose escalation study followed by a phase II study. Patients receive oral aurora kinase inhibitor MLN8237 once daily on days 1-14 and bortezomib IV on days 1, 4, 8 and 11. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment all patients are followed every 2 months for 1 year and then every 3 months for 1 year.

Conditions

• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Aurora A kinase inhibitor MLN8237	Given orally
DRUG	bortezomib	Given IV

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-09-01
• Completion: 2014-11-01
• First posted: 2009-12-17
• Last updated: 2016-05-25
• Results posted: 2016-05-25

Locations

6 sites across 1 country: United States