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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief 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).


Detailed Summary:
Sponsor: Array BioPharma

Current Primary Outcome:

  • Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 1 ]
  • Establish the maximum tolerated dose (MTD) of the study drug in combination with bortezomib ± dexamethasone + G-CSF. [ Time Frame: Part 1 ]
  • Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of best overall response [ Time Frame: Part 2 ]


Original Primary Outcome:

  • Characterize the safety profile of ARRY-520 when combined with bortezomib and dexamethasone as determined by adverse events, dose limiting toxicities, clinical laboratory tests, physical examination, body weight and electrocardiograms [ Time Frame: Until MTD is reached ]
  • Establish the maximum tolerated dose of ARRY-520 when combined with bortezomib and dexamethasone [ Time Frame: Until MTD is reached ]


Current Secondary Outcome:

  • Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of duration of response, time to progression, treatment-free interval and time to next treatment. [ Time Frame: Part 1 and Part 2 ]
  • Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 2 ]
  • Assess the pharmacokinetic (PK) drug interactions between ARRY-520 and bortezomib in terms of plasma concentration-time profiles. [ Time Frame: Part 2 ]


Original Secondary Outcome:

  • Assess the efficacy of ARRY-520 when combined with bortezomib and dexamethasone as determined by serum/urine protein and immunofixation electrophoresis, serum free light chain, bone marrow aspirate/biopsy, CRP, LDH and beta-2 microglobulin [ Time Frame: Every 4 weeks ]
  • Assess the efficacy of ARRY-520 when combined with bortezomib and dexamethasone as determined by best overall response, time to progression, treatment-free interval, and time to next treatment [ Time Frame: Every 4 weeks ]
  • Assess potential markers for patient selection and measurement of the biological activity of ARRY-520 when combined with bortezomib and dexamethasone in hematological tumor cells and peripheral blood [ Time Frame: Every 4 weeks ]


Information By: Array BioPharma

Dates:
Date Received: November 24, 2010
Date Started: December 2010
Date Completion:
Last Updated: April 21, 2016
Last Verified: April 2016