A Phase 1, First-in-Human, Open Label Study Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ABBV-438 in Adult Subjects With Relapsed or Refractory Multiple Myeloma
Summary
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.
Arms & interventions
- DrugABBV-438
Intravenous (IV)
Outcome measures
Primary
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.
Time frame: Up to Approximately 69.5 Months
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.
Time frame: Up to Approximately 69.5 Months
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.
Time frame: Up to Approximately 69.5 Months
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.
Time frame: Up to Approximately 69.5 Months
Secondary
Overall Response Rate (ORR)
Time frame: Up to Approximately 69.5 Months
Number of Participants Achieving VGPR or Better
Time frame: Up to Approximately 69.5 Months
Duration of Response (DOR) in Participants who Achieved PR or VGPR or CR or sCR
Time frame: Up to Approximately 69.5 Months
Progression-free survival (PFS)
Time frame: Up to Approximately 69.5 Months
Overall survival (OS)
Time frame: Up to Approximately 69.5 Months
Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-438
Time frame: Up to Approximately 69.5 Months
Maximum Observed Plasma Concentration (Cmax) of ABBV-438
Time frame: Up to Approximately 69.5 Months
Time to Cmax (Tmax) of ABBV-438
Time frame: Up to Approximately 69.5 Months
t1/2 (Half-life) of ABBV-438
Time frame: Up to Approximately 69.5 Months
Eligibility criteria
Study locations (5)
City of Hope National Medical Center /ID# 280273
Duarte, California, 91010
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 279067
Irvine, California, 92618
Colorado Blood Cancer Institute /ID# 280275
Denver, Colorado, 80218
City Of Hope - Atlanta. /ID# 280294
Newnan, Georgia, 30265
START Midwest /ID# 279035
Grand Rapids, Michigan, 49546