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

Phase 1

Completed

• Conditions: Multiple Myeloma, Plasma Cell Leukemia
• Interventions: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous; Drug: Bortezomib, proteasome inhibitor; intravenous or subcutaneous; Drug: Dexamethasone, steroid; oral; Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

• Registration Number: NCT01248923
• Lead Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

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 Description

Not available

Study Timeline

• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Study Start: 2010-12
• Primary Completion: 2016-03
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARRY-520 (Schedule 1) + bortezomib + G-CSF	Bortezomib, proteasome inhibitor; intravenous or subcutaneous	-
ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF	ARRY-520, KSP(Eg5) inhibitor; intravenous	-
ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF	Dexamethasone, steroid; oral	-
ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF	Dexamethasone, steroid; oral	-
ARRY-520 (Schedule 1) + bortezomib + G-CSF	ARRY-520, KSP(Eg5) inhibitor; intravenous	-
ARRY-520 (Schedule 1) + bortezomib + G-CSF	Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous	-
ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF	Bortezomib, proteasome inhibitor; intravenous or subcutaneous	-
ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF	Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous	-
ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF	ARRY-520, KSP(Eg5) inhibitor; intravenous	-
ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF	Bortezomib, proteasome inhibitor; intravenous or subcutaneous	-
ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF	Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous	-

Primary Outcome Measures

Name	Time	Method
Establish the maximum tolerated dose (MTD) of the study drug in combination with bortezomib ± dexamethasone + G-CSF.	Part 1
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.	Part 1
Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of best overall response	Part 2

Secondary Outcome Measures

Name	Time	Method
Assess the pharmacokinetic (PK) drug interactions between ARRY-520 and bortezomib in terms of plasma concentration-time profiles.	Part 2
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.	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.	Part 2

Trial Locations

Locations (13)

City of Hope; 🇺🇸 Duarte, California, United States

Clearview Cancer Institute; 🇺🇸 Huntsville, Alabama, United States

Emory University, Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Associates in Oncology/Hematology; 🇺🇸 Rockville, Maryland, United States

Arizona Clinical Research Center, Inc.; 🇺🇸 Tucson, Arizona, United States

NYU Cancer Center; 🇺🇸 New York, New York, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Charleston Hematology Oncology Associates; 🇺🇸 Charleston, South Carolina, United States

The Jones Clinic; 🇺🇸 Germantown, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Baylor Charles A. Sammons Cancer Center at Dallas; 🇺🇸 Dallas, Texas, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States