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

July 20, 2021 updated by: AbbVie

A First In Human Study of the MCL-1 Inhibitor, ABBV-467

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital /ID# 223354
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne /ID# 222066
      • Melbourne, Victoria, Australia, 3004
        • Alfred Health /ID# 214665
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Perth Blood Institute Ltd /ID# 226650
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital /ID# 225498
  • France
      • Creteil, France, 94000
        • Hopital Henri Mondor /ID# 214588
    • Pays-de-la-Loire
      • Nantes, Pays-de-la-Loire, France, 44000
        • CHU de Nantes, Hotel Dieu -HME /ID# 215480
  • Israel
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5239424
        • Sheba Medical Center /ID# 214065
  • Japan
    • Aichi
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 214696
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East /ID# 214697
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 220800
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital /ID# 214801
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron /ID# 214690
      • Madrid, Spain, 28027
        • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 214672
      • Malaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria /ID# 214756
    • Navarra, Comunidad
      • Pamplona, Navarra, Comunidad, Spain, 31008
        • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170
  • Taiwan
      • Taichung City, Taiwan, 40447
        • China Medical University Hosp /ID# 209323
    • Taipei
      • Taipei City, Taipei, Taiwan, 10002
        • National Taiwan University Hospital /ID# 209322
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719-1478
        • University of Arizona Cancer Center - North Campus /ID# 219102
    • California
      • Duarte, California, United States, 91010
        • City of Hope /ID# 209786
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Univ Med Ctr /ID# 221035
    • Rhode Island
      • Providence, Rhode Island, United States, 02903-4923
        • Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418
    • South Carolina
      • Greenville, South Carolina, United States, 29605-4255
        • Prisma Health Cancer Institute-Faris Road /ID# 219076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: ABBV-467 Dose Escalation
ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended phase 2 dose is determined.
Drug: ABBV-467
Intravenous (IV) Infusion
Experimental: Part B: ABBV-467 Dose Expansion
ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A.
Drug: ABBV-467
Intravenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events
Time Frame: 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.
Up to approximately 24 months after first dose of study drug
Change in Vital Signs
Time Frame: 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.
Baseline (Week 0) through approximately 24 months after first dose of study drug
Change in Electrocardiogram (ECG)
Time Frame: 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.
Baseline (Week 0) through approximately 24 months after first dose of study drug
Change in Cardiac Enzyme Levels
Time Frame: Baseline (Week 0) through approximately 24 months after first dose of study drug
Change in cardiac enzyme levels will be recorded.
Baseline (Week 0) through approximately 24 months after first dose of study drug
Incidence of Abnormal Clinical Laboratory Test Results
Time Frame: 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.
Baseline (Week 0) through approximately 24 months after first dose of study drug
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to approximately Day 197
Maximum Plasma Concentration (Cmax) of ABBV-467.
Up to approximately Day 197
Terminal Phase Elimination Half-life (t1/2)
Time Frame: Up to approximately Day 197
Terminal phase elimination half-life (t1/2) of ABBV-467
Up to approximately Day 197
Area Under the Plasma Concentration-Time Curve (AUCt)
Time Frame: Up to approximately Day 197
AUC from time 0 to time of last measurable concentration of ABBV-467.
Up to approximately Day 197
Area Under the Plasma Concentration-Time Curve (AUC0-infinity)
Time Frame: Up to approximately Day 197
AUC from time 0 to infinity of ABBV-467.
Up to approximately Day 197
Clearance of ABBV-467
Time Frame: Up to approximately Day 197
Clearance of ABBV-467.
Up to approximately Day 197

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 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).
Up to approximately 24 months after first dose of study drug
Clinical Benefit Rate (CBR)
Time Frame: 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.
Up to approximately 24 months after first dose of study drug
Duration of Response (DOR)
Time Frame: 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.
Up to approximately 24 months after first dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M19-025
  • 2018-003744-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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