The purpose of Substudy 1 is to characterize the safety and tolerability of ABBV-453 in combination with other antimyeloma agents in subjects with Relapsed or Refractory (R/R) Multiple Myeloma (MM) and to determine the recommended Phase 2 doses (RP2D) of ABBV-453 in combination with daratumumab + dexamethasone (Dd) in subjects with R/R MM.
During screening, the following procedures will be performed: medical/oncology history, adverse event assessment, current and previous medications, performance status, electrocardiogram, physical examination and vital signs, blood and urine collection, viral serologies, pregnancy test (for women of child-bearing potential), bone marrow aspirate, bone marrow core biopsy, BCL2 and t(11;14) central testing, skeletal survey, plasmacytoma evaluation, and tumor lysis syndrome (TLS) prophylaxis. In addition to the procedures described above, the following procedures will be performed during study cycles: biomarker research, pharmacokinetic (PK) testing, response assessment, infection prophylaxis, study diary, study drug dispensation, post-treatment follow-up visits, and survival follow-up visits.
ABBV-453 will be provided at no charge.
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA
Samuel Rubinstein
LCCC - Clinical Trials
Clinical or Medical
Interventional
Blood Conditions
Cancer (Multiple Myeloma)
25-0625