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

Phase 1

Completed

Interventions: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
Drug: Dexamethasone, steroid; oral

Brief 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).

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
ARRY-520 + dexamethasone + G-CSF support	Dexamethasone, steroid; oral	-
ARRY-520	ARRY-520, KSP(Eg5) inhibitor; intravenous	-
ARRY-520 + G-CSF support	ARRY-520, KSP(Eg5) inhibitor; intravenous	-
ARRY-520 + G-CSF support	Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous	-
ARRY-520 + dexamethasone + G-CSF support	ARRY-520, KSP(Eg5) inhibitor; intravenous	-
ARRY-520 + dexamethasone + G-CSF support	Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous	-

Primary Outcome Measures

Name	Time	Method
Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.	Part 1
Assess the efficacy of the study drug, with and without dexamethasone, in terms of response rate.	Part 2 and Part 3
Characterize the safety profile of the study drug in combination with dexamethasone in terms of adverse events, clinical laboratory tests and electrocardiograms.	Part 3

Secondary Outcome Measures

Name	Time	Method
Characterize the pharmacokinetics of the study drug.	Part 1
Assess the efficacy of the study drug, with and without dexamethasone, in terms of duration of response, progression-free survival, treatment-free survival, time to next treatment and overall survival.	Part 2 and Part 3
Assess the efficacy of the study drug in terms of response rate, duration of response, progression-free survival, treatment-free survival and time to next treatment.	Part 1
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.	Part 2
Explore potential biomarkers for pharmacodynamics (PD) and for patient selection.	Part 1, Part 2 and Part 3

Locations (5): MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
Emory University, Winship Cancer Institute
🇺🇸
Atlanta, Georgia, United States
Fred Hutchinson Cancer Research Center
🇺🇸
Seattle, Washington, United States
Fox Chase Cancer Center
🇺🇸
Philadelphia, Pennsylvania, United States
Karmanos Cancer Institute
🇺🇸
Detroit, Michigan, United States