A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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).
Phase:
Phase 1
Details
Lead Sponsor:
Array BioPharma Array Biopharma, now a wholly owned subsidiary of Pfizer