Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

Exclusion Criteria

• •Eligible for and agree to BM aspirate prior to treatment start
• •Measurable disease M component in serum (≥ 0.5 g/dL) and/or urine (≥ 0.2 g excreted in a 24 hour collection sample)
• •Must have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or those who are double refractory to a PI and an immunomodulatory agent and have demonstrated disease progression (DP) on or within 60 days of completion of the last therapy; participants previously treated with an alkylating agent, in addition to an IMiD or proteasome inhibitor, are allowed to enroll in the trial
• •Participants must have adequate liver, kidney, and bone morrow function
• •Participants with a history of chronic heart failure must have cardiac ECHO indicating left ventricular ejection fraction (LVEF) ≥ 45% within 21 days prior to first dose of study drug
• •Participants in the combination therapy arms must be eligible to receive pomalidomide/dexamethasone, bortezomib/dexamethasone or lenalidomide/dexamethasone or other approved agents per current prescribing information for MM.
• •Participants who will receive combination therapy with Pomalidomide/Dexamethasone must have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy
• •Received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, any investigational therapy or herbal therapy within a period of 21 days prior to the first dose of ABBV-838, and have unresolved toxicities ≥ grade 2
• •Concurrent metastatic solid tumors
• •Non-Measurable M Protein (serum or urine) and measurable sFLC (\< 100 mg/mL)
• •Major surgery within 21 days prior to the first dose of ABBV-838
• •Clinically significant uncontrolled condition(s) including but not limited to the following:
• •Grade ≥ 3 peripheral neuropathy or grade 2 peripheral neuropathy with pain Uncontrolled hypercalcemia Active uncontrolled infection Symptomatic congestive heart failure Unstable angina pectoris or cardiac arrhythmia Psychiatric illness/social situation that would limit compliance with the study
• •Major immunologic reaction to any IgG containing agent or auristatin based agent
• •Participants who are taking strong CYP3A4 inhibitors
• •Positive for HIV (Human Immunodeficiency Virus) or with active hepatitis B and/or C
• •Corneal pathology that would limit evaluation of loss in visual acuity associated with corneal deposits.
• •Prior exposure to pomalidomide for subjects enrolling in the pomalidomide/dexamethasone combination arm.