Spots Global Cancer Trial Database for A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
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Trial Identification
Brief Title: A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
Official Title:
Study ID: NCT01248923
Conditions
Interventions
Study Description
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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Clearview Cancer Institute, Huntsville, Alabama, United States
Arizona Clinical Research Center, Inc., Tucson, Arizona, United States
City of Hope, Duarte, California, United States
Emory University, Winship Cancer Institute, Atlanta, Georgia, United States
Associates in Oncology/Hematology, Rockville, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
NYU Cancer Center, New York, New York, 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
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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