The primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and the recommended phase two dose (RPTD) of ABT-199 when administered in subjects with relapsed /refactory multiple myeloma who are receiving bortezomib and dexamethasone as their standard therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
ABT-199 at cohort-defined dosing schedules and dose levels. ABT-199 at defined dose and schedule for Safety Expansion cohort
Bortezomib at cohort-defined dosing schedules and dose levels. Bortezomib at defined dose and schedule for Safety Expansion cohort
Dexamethasone at cohort-defined dosing schedules and dose levels. Dexamethasone at defined dose and schedule for Safety Expansion cohort.
University of Arizona Cancer Center - North Campus /ID# 117876
Tucson, Arizona, United States
Mayo Clinic /ID# 121495
Jacksonville, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 117477
Chicago, Illinois, United States
Determination of peak concentration (Cmax) of ABT-199
Blood samples for pharmacokinetic analysis of ABT-199 will be collected at designated timepoints
Time frame: Approximately 5 days in Cycle 1 then on Day 1 of Cycles 2,4,6,8
Determine maximum tolerated dose (MTD), and recommended phase two dose (RPTD) of ABT-199
ABT-199 will be dose-escalated until the largest dose is reached that is determined to be safe based on adverse event reporting and dose-limiting toxicities information from all subjects.
Time frame: Minimum first cycle of dosing (21 days)
Number of participants with adverse events
Collect all adverse events at each visit.
Time frame: From subject's first dose of ABT-199 until 30 days after subject's last dose of ABT-199; up to 2 years following last subject first dose.
Determination of trough concentration (Ctrough) of ABT-199
Blood samples for pharmacokinetic analysis of ABT-199 will be collected at designated timepoints
Time frame: Approximately 5 days in Cycle 1 then on Day 1 of Cycles 2,4,6,8
Determination of area under the concentration versus time curve (AUC) of ABT-199
Blood samples for pharmacokinetic analysis of ABT-199 will be collected at designated timepoints
Time frame: Approximately 5 days in Cycle 1 then on Day 1 of Cycles 2,4,6,8
Determine recommended phase two dose (RPTD) of ABT-199
ABT-199 will be dose-escalated until the largest dose is reached that is determined to be safe based on adverse event reporting and dose-limiting toxicities information from all subjects.
Time frame: Minimum first cycle of dosing (21 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Michigan Hospitals /ID# 80353
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester /ID# 77235
Rochester, Minnesota, United States
Peter MacCallum Cancer Ctr /ID# 79553
Melbourne, Victoria, Australia
Royal Melbourne Hospital /ID# 79533
Parkville, Victoria, Australia
CHRU Lille - Hôpital Claude Huriez /ID# 77234
Lille, Hauts-de-France, France
CHU de Nantes, Hotel Dieu -HME /ID# 78773
Nantes, France
Duration of Response
Number of days from the day of initial response is objectively documented to the day that disease progression is objectively documented
Time frame: Measured up to 48 months after the last subject has enrolled in the study
Objective Response Rate
The proportion of subjects with response using International Myeloma Working Group (IMWG) response criteria will be computed for all subjects with active disease at baseline (in the opinion of the investigator)
Time frame: Measured up to 48 months after the last subject has enrolled in the study
Time to Disease Progression
Number of days from the date of the first dose of ABT-199 to the date of the subject's disease progression.
Time frame: Measured up to 48 months after the last subject has enrolled in the study