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

Overview

This first-in-human study will evaluate the safety and tolerability of ABBV-467 (an MCL-1 Inhibitor) in adult participants with relapsed/refractory multiple myeloma

SparkCures ID 1059
Trial Phase Phase 1
Enrollment 54 Patients
Treatments
Tags
Trial Sponsors
  • AbbVie
NCT Identifier

NCT04178902

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.

US Trial Locations

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more


Lifespan Cancer Institute The Miriam Hospital

Providence, RI

Prisma Health Greenville Memorial Hospital

Greenville, SC

Arizona
California
New Jersey
Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more

Rhode Island
Lifespan Cancer Institute The Miriam Hospital

Providence, RI

South Carolina
Prisma Health Greenville Memorial Hospital

Greenville, SC

International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.

Resources

There are no resources, links or videos to display for this clinical trial.

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