This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Varying doses of ABBV-838
Administered orally per the label.
Administered orally per the label.
The University of Chicago Medical Center /ID# 139403
Chicago, Illinois, United States
Maximum plasma concentration (Cmax) of ABBV-838
The maximum plasma concentration (Cmax: measured in ng/ml) is the highest concentration that a drug achieves in the blood after the first dose, but before administration of a second dose.
Time frame: Cycle 1 Day 1 (C1D1) and C3D1 pre- and post-dose; C1D4, C1D8, C1D15, C2D1, C2D15, C3D4, C3D8, C3D15, C4D1, and all subsequent ABBV-838 pre-dose dosing cycles
Maximum tolerated dose of ABBV-838
The highest dose level at which less than 2 of 6 subjects or less than 33% of (if cohort is expanded beyond 6) subjects experience a dose limiting toxicity.
Time frame: Up to 2 years from first dose of study
Preliminary activity of ABBV-838 monotherapy
Response evaluation will be based on International Myeloma Working Group (IMWG) Response Criteria.
Time frame: At screening, Cycle 1 Day 15 (C1D15), C3D15, C4D1, and for subjects who have been on ABBV-838 for ≥ 6 cycles, radiologic tumor assessments may be performed every 3 cycles per Investigator discretion up to approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Michigan Medical Center /ID# 139402
Ann Arbor, Michigan, United States
Washington University School of Medicine /ID# 135708
St Louis, Missouri, United States
Mount Sinai Medical Center /ID# 133569
New York, New York, United States
The Sarah Cannon Research Institute /ID# 135814
Nashville, Tennessee, United States
CHRU de Lille, Hopital Claude Huriez /ID# 133634
Lille, France
CHU de Nantes, Hotel Dieu - HME /ID# 133633
Nantes, France
CHU de la miletrie, Centre d'investigation clinique /ID# 147542
Poitiers, France
Universitaetsklinikum Koeln /ID# 141535
Cologne, Germany
Universitaetklinikum Dresden /ID# 141860
Dresden, Germany
...and 9 more locations