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 108 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

Please visit the ClinicalTrials.gov page for historical site information.

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