Cancer, Multiple Myeloma (MM)
Conditions
Keywords
Multiple Myeloma (MM), Relapse/Refractory, Cancer, ABBV-467
Brief summary
This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).
Interventions
DRUGABBV-467
Intravenous (IV) Infusion
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of multiple myeloma (MM). * Measurable disease defined as at least 1 of the following: * Serum monoclonal protein \>= 1g/dL. * Urine M-protein \>= 200mg/24 hours. * Serum immunoglobulin free light chain (FLC) \>= 10 mg/dL (100 mg/L), provided serum FLC ratio is abnormal. * Relapsed after or are refractory or intolerant to all established MM therapies that are both known to provide clinical benefit and locally available. * Received at least 3 prior lines of therapy including 1 or more immunomodulatory agents, 1 or more proteasome inhibitors, and 1 or more anti-CD38 monoclonal antibodies. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Adequate hematologic, renal and hepatic function as described in the protocol. * Echocardiogram with ejection fraction \>= 50% and no other clinically significant findings that would increase the participant's susceptibility to cardiac toxicity.
Exclusion criteria
* Prior exposure to any targeted myeloid cell leukemia-1 (MCL-1) inhibitor. * Antineoplastic therapy (including any cytotoxic, targeted and/or investigational therapy; but not including corticosteroids), within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug and through the last dose of study drug. * Autologous stem cell transplant within 90 days prior to start of study drug. * Allogenic stem cell transplant within 180 days prior to start of study drug. * History of acute or chronic pancreatitis. * Significant unresolved liver disease. * History of hepatitis B or human immunodeficiency virus (HIV) infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of ABBV-467 | Up to approximately Day 197 | Clearance of ABBV-467. |
| Terminal Phase Elimination Half-life (t1/2) | Up to approximately Day 197 | Terminal phase elimination half-life (t1/2) of ABBV-467 |
| Area Under the Plasma Concentration-Time Curve (AUCt) | Up to approximately Day 197 | AUC from time 0 to time of last measurable concentration of ABBV-467. |
| Area Under the Plasma Concentration-Time Curve (AUC0-infinity) | Up to approximately Day 197 | AUC from time 0 to infinity of ABBV-467. |
| Number of Participants with Adverse Events | Up to approximately 24 months after first dose of study drug | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator will assess the relationship of each event to the use of study drug as being of reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. |
| Change in Vital Signs | Baseline (Week 0) through approximately 24 months after first dose of study drug | Change in vital signs like systolic and diastolic blood pressure will be assessed. |
| Change in Electrocardiogram (ECG) | Baseline (Week 0) through approximately 24 months after first dose of study drug | 12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration. |
| Change in Cardiac Enzyme Levels | Baseline (Week 0) through approximately 24 months after first dose of study drug | Change in cardiac enzyme levels will be recorded. |
| Incidence of Abnormal Clinical Laboratory Test Results | Baseline (Week 0) through approximately 24 months after first dose of study drug | Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed. |
| Maximum Observed Plasma Concentration (Cmax) | Up to approximately Day 197 | Maximum Plasma Concentration (Cmax) of ABBV-467. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Benefit Rate (CBR) | Up to approximately 24 months after first dose of study drug | CBR evaluated per adapted International Myeloma Working Group (IMWG) criteria and is defined as minimal response (MR) + PR + VGPR + CR + sCR. |
| Duration of Response (DOR) | Up to approximately 24 months after first dose of study drug | DOR is defined as the time between date of first response and the first occurrence of progression or death from any cause, whichever comes first. |
| Overall Response Rate (ORR) | Up to approximately 24 months after first dose of study drug | ORR evaluated per adapted International Myeloma Working Group (IMWG) criteria and defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR). |
Countries
Australia, France, Israel, Japan, Spain, Taiwan, United States
Outcome results
None listed