A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma

Phase 1TerminatedNCT04178902

AbbVie8 enrolled

Overview

This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma (MM)Cancer

Interventions

ABBV-467DRUG

Intravenous (IV) Infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (24)

Outcomes

Primary Outcomes

Number of Participants with Adverse Events

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.

Time frame: Up to approximately 24 months after first dose of study drug

Change in Vital Signs

Change in vital signs like systolic and diastolic blood pressure will be assessed.

Time frame: Baseline (Week 0) through approximately 24 months after first dose of study drug

Change in Electrocardiogram (ECG)

12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.

Time frame: Baseline (Week 0) through approximately 24 months after first dose of study drug

Change in Cardiac Enzyme Levels

Change in cardiac enzyme levels will be recorded.

Time frame: Baseline (Week 0) through approximately 24 months after first dose of study drug

Incidence of Abnormal Clinical Laboratory Test Results

Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.

Time frame: Baseline (Week 0) through approximately 24 months after first dose of study drug

Data from ClinicalTrials.gov

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Secondary Outcomes

Overall Response Rate (ORR)

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).

Time frame: Up to approximately 24 months after first dose of study drug

Clinical Benefit Rate (CBR)

CBR evaluated per adapted International Myeloma Working Group (IMWG) criteria and is defined as minimal response (MR) + PR + VGPR + CR + sCR.

Time frame: Up to approximately 24 months after first dose of study drug

Duration of Response (DOR)

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.

Time frame: Up to approximately 24 months after first dose of study drug