Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety, tolerability, and how ABBV-438 moves through the body, in adult participants with relapsed/refractory (R/R) MM. Adverse events, tolerability, how ABBV-438 moves through the body will be assessed.
ABBV-438 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms broken into 2 parts. ABBV-438 will be given alone and multiple doses will be explored. This study will include a dose escalation phase (Part 1) to determine the best dose of ABBV-438, followed by a dose expansion phase (Part 2) to confirm the dose. Approximately 127 adult participants with R/R MM will be enrolled in the study in approximately 24 sites worldwide.
Participants will receive intravenous (IV) ABBV-438 alone first in multiple doses in the dose escalation phase (Part 1); then in 1 of 2 doses from Part 1 in the dose expansion phase (Part 2). The overall study duration will be approximately 69.5 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy;
Refractory defined as disease that is nonresponsive (failure to achieve minimal response) while on last therapy, or progresses within 60 days of last therapy.
Serum M-protein >= 0.5 g/dL (>=5 g/L); OR;
Urine M-protein >= 200 mg/24 hours; OR;
Known history of Central Nervous System involvement by MM.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
Parallel
ABBV-438
DrugIntravenous (IV)
Number of Participants With Adverse Events (AE)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence, whether associated with study drug or not, that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event requiring medical or surgical intervention to prevent serious outcome.
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Clinical laboratory parameters included tests of hematology and chemistry. The investigator will assess the results for clinical significance.
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Vital sign parameters included body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate. The investigator will assess the results for clinical significance.
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with the achievement of partial response (PR) or very good partial response (VGPR) or complete response (CR) or stringent complete response (sCR) as assessed by investigators per IMWG 2016 criteria.
Number of Participants Achieving VGPR or Better
VGPR or better is defined as the percentage of participants with the achievement of VGPR , CR, or sCR as assessed by investigators per IMWG 2016 criteria.
Duration of Response (DOR) in Participants who Achieved PR or VGPR or CR or sCR
DOR is defined as confirmed sCR, CR, VGPR, or PR as the time from the initial response of PR (or better) per investigator review according to IMWG 2016 criteria, to disease progression or death of any cause, whichever occurs earlier.
Progression-free survival (PFS)
PFS defined as time from first study treatment to a documented disease progression according to IMWG 2016 criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.
