Overview

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

Status:
Completed
Trial end date:
2016-03-16
Target enrollment:
Participant gender:
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).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Array BioPharma
Pfizer
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Filanesib
Lenograstim
Sargramostim