Refractory Multiple Myeloma Clinical Trial
Official title:
Phase I/II Study of Combination of Aurora Kinase Inhibitor MLN8237 and Bortezomib in Relapsed or Refractory Multiple Myeloma
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.
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 and 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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